- Email: [email protected]
Opioid utilization is minimal after outpatient pediatric urologic surgery
Journal Pre-proof Opioid Utilization is Minimal after Outpatient Pediatric Urologic Surgery Aylin N. Bilgutay, Hannah Hua, Mary Edmond, Emily S. Blum, Edwin A. Smith, James M. Elmore, Hal C. Scherz, Michael Garcia-Roig, Andrew J. Kirsch, Wolfgang H. Cerwinka PII:
S1477-5131(19)30341-9
DOI:
https://doi.org/10.1016/j.jpurol.2019.10.021
Reference:
JPUROL 3305
To appear in:
Journal of Pediatric Urology
Received Date: 23 July 2019 Accepted Date: 23 October 2019
Please cite this article as: Bilgutay AN, Hua H, Edmond M, Blum ES, Smith EA, Elmore JM, Scherz HC, Garcia-Roig M, Kirsch AJ, Cerwinka WH, Opioid Utilization is Minimal after Outpatient Pediatric Urologic Surgery, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.021. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.
Opioid Utilization is Minimal after Outpatient Pediatric Urologic Surgery Aylin N. Bilgutay,1,2 Hannah Hua,3 Mary Edmond,3 Emily S. Blum,1,2,4 Edwin A. Smith,1,2 James M. Elmore,1,2 Hal C. Scherz,1,2 Michael Garcia-Roig,1,2 Andrew J. Kirsch,1,2 Wolfgang H. Cerwinka,1,2 1
Children’s Healthcare of Atlanta, Atlanta, GA, Department of Pediatric Urology Emory University, Atlanta, GA, Department of Pediatric Urology 3 Children’s Healthcare of Atlanta, Atlanta, GA, Department of Statistics, Advanced Analytics Team 4 Global Center for Medical Innovation, Atlanta, GA 2
Corresponding author Aylin N Bilgutay Address: 5730 Glenridge Drive, Suite 200, Sandy Springs, GA 30328 Telephone: (404) 252-5206 Fax: (404) 252-1268 Email: [email protected]
Key Words: Opioid, population health, postoperative pain, prospective
Abstract/Extended Summary Introduction: There are no guidelines for opioid use after pediatric urologic surgery, and it is unknown to what extent prescriptions written for these patients may be contributing to the opioid epidemic in the United States. We sought to characterize opioid utilization in a prospective fashion following outpatient pediatric urologic surgery at our institution.
Materials and Methods: After obtaining IRB approval, we prospectively recruited pediatric patients undergoing outpatient urologic surgery. All patients and families were counseled regarding appropriate use of over-the-counter pain medications as first-line agents, with opioids for breakthrough pain only. All patients received an opioid prescription (ORx), which we attempted to standardize to 10 doses. Parents were provided with a log for keeping track of pain medication administration. Postoperative surveys were sent at various time-points after surgery to assess utilization of pain medications at home. We quantified unused opioids prescribed and evaluated factors potentially associated with opioid use.
Results: Two hundred and two patients were recruited. All patients were male, with a median age of 2.7 years (IQR 5.5, range 0.5-17.9 years). One hundred and fifty-four children underwent penile surgery, 22 underwent scrotal surgery, and 27 underwent inguinal surgery. Nearly half of our study patients were black, 33.2% were white, 12.9% were Latino, and 4.0% were Asian. The median number of doses prescribed was 10 (IQR 0, range 4.0-20.8). Postoperative surveys were completed by 80.7% of study patients. The median number of opioid doses used was 0 (IQR 2), while the mean was 1.28 (SD 1.98). None of the factors evaluated (including patient age, surgery type, perioperative pain management techniques, length of surgery, and insurance type) were associated with amount of opioid used at home after surgery, as utilization was equally low across all groups.
Discussion and Conclusions: Ensuring adequate postoperative pain control for children is critical, yet it is also important to minimize excess ORx. We found that the majority of pediatric patients used 0-2 doses of prescription pain medication after discharge following outpatient urologic surgery, representing a small percentage of the total prescribed amount. Low utilization was seen irrespective of patient age, procedure, and perioperative factors. These data can be used to 1
guide perioperative patient and family counseling and to guide future efforts to standardize ORx following outpatient pediatric urologic surgery.
Postop Opioid Doses Procedure Type N = 169* Mean (Range, Std Dev) Median (IQR) P value Penile 132 1.31 (0-11, 2.03) 0 (2) 0.78 Inguinal 20 1 (0-5, 1.41) 0.5 (1.5) Scrotal 17 1.41 (0-8, 2.24) 0 (2) Age (Years) N = 169* Mean (Range, Std Dev) Median (IQR) P value <1 37 1.41 (0-7, 1.86) 1 (2) 0.82 1 to < 3 52 1.17 (0-5, 1.65) 0 (2) 3-10 55 1.18 (0-11, 2.22) 0 (2) > 10 25 1.56 (0-8, 2.29) 0 (3) Table 1: Number of postoperative opioid doses by procedure type and age group *Includes patients with complete surveys (N=163) and those with incomplete surveys who never filled the ORx (N=6)
Introduction Due to their narrow therapeutic index, addictive nature, and potential for serious or even life-threatening consequences of abuse and overdose, opioid prescriptions are tightly regulated in the United States (US) at both the state and federal level.1 Yet in spite of these measures, the US is facing an opioid crisis that has been fueled in part by prescription drugs. Over 42,000 people died from opioid overdose in the US in 2016; 40% of those deaths involved a prescription medication.2 New regulations have been implemented in several states in response to the epidemic. Georgia has recently instituted a Prescription Drug Monitoring Program (PDMP) to track all opioid prescriptions filled in the state, with the goal of decreasing the potential for abuse. All opioid prescribers in Georgia are required to register with the PDMP, and dispensers must enter information within 24 hours of filling a prescription.3 Similar programs have been successful in other states. In Florida, oxycodone-caused mortality declined abruptly in 2011 after a PDMP was established.4 A recent study comparing data across all 50 states and the District of Columbia from 1999-2014 found that more robust PDMPs were associated with fewer prescription opioid overdose deaths.5
Overprescription of postoperative opioid has been reported in the adult urologic literature. Bates et al. found that 67% of the patients in their study had remaining opioids following urologic surgery. Ninety-two percent had not received any instruction for its disposal, and 91% kept the surplus medication in the home.6 Pediatric specialists may also prescribe 2
more opioid than needed. In their 2017 survey-based study including 343 pediatric inpatients (98% postoperative), Monitto et al. reported that 58% of prescribed opioid doses were not consumed.7 Only 19% of families were instructed regarding how to dispose of remaining opioids, and an even smaller minority (4%) actually did so. We hypothesized that opioids are overprescribed after outpatient pediatric urologic surgery. The aims of our study were to quantify postoperative pain and to determine the requirement for analgesics, and specifically the utilization of opioids, in this patient population.
Materials and Methods After obtaining IRB approval, we recruited pediatric patients undergoing outpatient urologic surgery at our institution between August 2018 and April 2019. A power analysis using a standard power of 0.8 revealed that a sample size of 116 patients would be required to show a 25% difference in proportion of opioid used between groups. We therefore set a goal to recruit 200 patients, taking into consideration that our response rate would not be 100% and that the expected true difference (if any) was unknown and possibly smaller than hypothesized. Patients aged 6 months to 18 years undergoing outpatient urologic surgery by one of 7 attendings or 1 junior attending were eligible. Informed consent was obtained from the parent or legal guardian of each patient. In accordance with IRB policies, age-appropriate written or verbal assent was obtained from all patients ≥ 5 years old. Demographic, preoperative, and intraoperative data were prospectively collected. We noted use of opioid or nonopioid premedications, use of caudal or other blocks, surgery length, quantity of intraoperative opioids used, use of ketorolac, and quantity of opioids given in the post-anesthetic care unit. All perioperative opioids were converted to oral morphine milligram equivalents per patient kilogram (MME/kg).
Parents of children <4 years old were counseled regarding pain assessment using the Face Legs Activity Cry Consolability (FLACC) pain scale. Parents of children ≥4 years old were counseled regarding pain assessment using the Faces Pain Scale, Revised (FPS-R). Both tools are validated for pain assessment in the pediatric population with a scale from 0-10.8-11 Parents were instructed to use acetaminophen and/or ibuprofen as needed for pain, and were given detailed written dosing information including concentration, volume, and frequency, with dose calculated based on their child’s weight 3
(10 mg/kg). Parents were informed that they could give each over-the-counter (OTC) medication every 4-6 hours prn, so that if alternated, the child could receive a non-opioid pain medication every 2-3 hours if needed. All parents also received an opioid prescription (hydrocodone-acetaminophen dosed at 0.1 mg/kg, appropriately formulated based on patient weight and ability to swallow pills), which they were instructed to use for breakthrough only. We chose this postoperative pain management regimen (OTC medications prn as first-line agents with opioid-acetaminophen combination for breakthrough) based on our usual practice patterns. Prior to study initiation, all patients ≥ 6 months old typically received an ORx; however, there was significant variation in the number of doses, with 10-20 doses routinely being prescribed. We therefore attempted to standardize postop ORx to 10 doses per study patient. Parents were counseled regarding the risk of acetaminophen toxicity and were instructed to wait at least 6 hours between doses of any acetaminophen-containing medications. Instructions were given regarding safe storage and disposal of unused opioids.
Parents were given a blank log to fill in pertinent information about any pain medication given in real-time, including name of drug, date/time of administration, and associated pain score. Study data were subsequently collected and managed with the Research Electronic Data Capture (REDCap) system. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.12,13
Links to online REDCap surveys were emailed to parents starting 24 hours after surgery, asking whether the child had taken any acetaminophen or ibuprofen. If they answered ‘yes’ for either medication, they were prompted to fill in the number of doses given, date/time of each dose, and associated pain score. They were also asked whether they had filled the ORx. If so, they were asked whether the patient had received any prescription medication, and if so, how many doses, date/time of each dose, and associated pain score. The final question was whether they anticipated giving additional pain medications. If they answered ‘yes,’ then additional surveys were sent out 1-2 days later, allowing the 4
parent to complete up to 10 postoperative surveys. If the initial or follow-up surveys were not completed within 48 hours, up to 5 reminder emails were sent. Parents were called by telephone in an attempt to obtain the above information if they did not have access to email, preferred not to give their email address, or if they did not fill out the emailed survey after 5 reminders. PDMP query allowed us to determine whether the ORx had been filled for those patients whose parents did not fill out email surveys and who were unable to be reached by telephone.
The data were analyzed for evidence of association between postoperative opioid doses and patient age, surgery type/length, and perioperative pain management techniques. Statistical analysis was conducted in SAS Enterprise Guide 7.1 (SAS Institute., Cary, NC, USA). Analyses were two-sided, with p values < 0.05 considered statistically significant. Pearson’s correlation coefficient was obtained to assess for correlation between surgery length and quantity of intraoperative and/or postoperative opioid administered. T tests were applied to evaluate for association between postop opioid doses and preop treatments, such as presence of caudal block, and for association between postop opioid doses and patient balanitis xerotica obliterans (BXO) status. Chi-square tests were implemented to analyze the relationship between opioid use and Medicaid status. One-way ANOVA was used to compare pain scores reported at time of administration for the three different pain drugs. To test if postop opioid doses were related to age, patients were divided into four age groups (< 1 year old, 1-3, 3-10, and > 10 years old). One-way ANOVA was then used to compare the postop opioid doses among these four age groups. To evaluate whether postop opioid doses varied with procedure type, patients were divided into three groups based on incision location (penile, inguinal, or scrotal); one-way ANOVA was used to compare the postop opioid doses between these groups.
Results Two hundred and two patients were recruited. Although not mandated by study design, all of the participants were male. Patient age at time of surgery ranged from 0.5 to 17.9 years (median 2.7, IQR 5.5). Nearly half of the patients were black (49.5%), 33.2% white, 12.9% Latino, 4.0% Asian.
5
Patients underwent a variety of surgeries, including circumcision (94), circumcision revision (30), scrotal orchiopexy (20), inguinal orchiopexy (14), division of penile bands (12), inguinal hernia repair (11), meatoplasty (8), phalloplasty (6), hypospadias repair (3), inguinal orchiectomy (1), scrotal orchiectomy (1), scrotal hydrocele (1), and excision of penile lesion (1). For analysis, the procedures were grouped according to incision location, with 154 penile (76.2%), 26 inguinal (12.9%), and 22 scrotal (10.9%). Sixty-six percent of the study patients were insured by Medicaid.
Thirty-four percent of patients received an oral opioid premedication in the preoperative holding area with a median dose of 0.13 MME/kg (IQR 0.04), while 61.9% received a nonopioid premedication consisting of acetaminophen, midazolam, or both. Fifty-seven percent of patients underwent caudal block, while 39.6% received other block types (penile or cord, depending on surgical site) and/or peri-incisional local. Thirty-three percent of patients received intravenous ketorolac intraoperatively. The median total intraoperative opioid received was 0.16 MME/kg (IQR 0.11, range 0-0.51).
Of 78 patients in the FPS-R group, 63 (80.8%) completed surveys as requested (i.e. until no additional medication administration was anticipated). Three FPS-R patients without responses did not fill their ORx, and we were therefore able to deduce that no opioid was used by those patients. One hundred of 124 FLACC group patients (80.6%) completed surveys as requested. Three FLACC patients without responses did not fill their ORx, and we were therefore able to deduce that no opioid was used. The maximum number of surveys completed for a single patient was 4. Three families completed at least one survey, but indicated that additional pain medications were anticipated then did not complete follow-up surveys as requested. The data for these patients were considered incomplete and were not included in the analysis.
The median number of opioid doses prescribed was 10 (IQR 0, range 4.0-20.8), while the median number of opioid doses used was 0 (IQR 2, range 0-11). The mean number of opioid doses used was 1.28 (SD 1.98). No difference in amount of opioid used was seen based on procedure type or patient age (Table 1). The median number of excess doses prescribed per patient was 10 (IQR 2). 6
Despite being counseled to try both acetaminophen and ibuprofen before resorting to the ORx, 11.0% used the ORx for pain control without trying either OTC medication. An additional 22.7% used an opioid and only one OTC medication. Seven percent used no pain medication of any kind. The complete breakdown of medication use is shown in Table 2.
Fifty-six percent of the patients who completed surveys reported acetaminophen use. The median number of acetaminophen doses given was 1 (IQR 3). For those who gave any acetaminophen, the median number of doses was 3 (IQR 4). Fifty-seven percent of patients reported ibuprofen use. The median number of ibuprofen doses given was 1 (IQR 3). For those who gave any ibuprofen, the median dose number was 3 (IQR 3). Fifty percent of patients who completed surveys (82/163) reported opioid use. When taking into account 6 additional patients who did not complete surveys but never filled the script, we know that only 48.5% (82/169) used opioid. Overall, the median number of opioid doses given was 0 (IQR 2). For those who gave any opioid at all, median dose number was 2 (IQR 3).
Patients received ibuprofen and acetaminophen for a median of 2 days (IQR 2) and opioid for a median of 2 (IQR 3) days. Some patients received analgesics longer, up to a maximum of 10 days for acetaminophen, 7 days for ibuprofen, and 6 days for opioid (Figure 1a-c).
Medicaid status was not associated with likelihood of using any opioids (p=0.60) or only opioids (p=0.71) for postoperative pain control at home (Table 3). Perioperative factors, including use of opioid or non-opioid premedication, use of caudal or other block, use of intraoperative ketorolac, and length of surgery were not associated with number of opioid doses or amount of opioid in MME/kg used postoperatively. A moderate positive linear relationship was found between surgery length and quantity of intraoperative opioids used (Pearson correlation coefficient 0.35, p<0.0001). The presence of a caudal block was associated with decreased intraoperative opioid use compared to other blocks such as penile or cord blocks (mean 0.13 MME/kg for those with caudal block versus mean 0.23 MME/kg for those with other blocks; p<0.0001).
7
Pain scores at time of medication administration ranged from 0-10 for all three medications. Yet overall, pain scores recorded at time of opioid provision were significantly higher than pain scores at time of OTC medication administration (p<0.0001; Table 4).
Seventy-six percent of patients filled their ORx. Likelihood of filling the scripts did not vary with patient age or with procedure type.
While the majority of patients used no opioids or very few doses, it is worth noting the presence of outliers skewing the data to the right, up to a maximum of 11 doses (Figure 1d). The maximum number of postoperative opioid doses was recorded after a circumcision in a patient with BXO. The second highest number of opioid doses recorded was 9 after a circumcision in a patient without BXO. There were only 4 BXO patients in our cohort – the other 3 required 0, 1, and 5 doses each. Although the mean (4.25 vs 1.37) and median (3 vs 0) number of opioid doses after circumcision was higher in patients with BXO compared to those without, we were unable to show statistical significance (p=0.33) due to the small number of BXO patients. Only one patient in the entire cohort (0.5%) required additional opioids beyond what was initially prescribed. That patient had undergone hypospadias repair with a catheter in place and also required a refill of oxybutynin.
Discussion Although pain control is an important part of postoperative patient care, the existing medical literature indicates a lack of formal training for surgical trainees on this topic. A recent survey of Canadian chief urology residents found that nearly three-quarters of respondents had received most of their pain management education from other trainees.14 In the same study, most respondents agreed or strongly agreed that formalized education on this subject would have been beneficial. A 2018 survey of general surgery residents at a tertiary academic center in the US revealed that >90% of respondents had not been formally educated regarding opioid prescription best practices or pain management in general.15
8
Lack of formal education may contribute to observed variability in practice patterns. In 2018, Eid et al. reported variability in outpatient ORx after the same type of surgery at a single academic center.16 Other authors have similarly reported variable postoperative ORx practices among surgeons and surgical trainees.17,18 Variation in opioid use has also been reported among pediatric inpatients at different hospitals in the US.19 Morrison et al. published a survey of members of the Societies for Pediatric Urology in 2014, which revealed no consensus in perioperative and postoperative pain management techniques after common pediatric urologic procedures.20 Postsurgical prescriptions have been associated with overdose and misuse. Brummet et al. reported the incidence of new, persistent opioid use in US adults to be similar after major or minor surgery, ranging from 5.9-6.5%, while the incidence in a nonoperative control group was only 0.4%.21 A recent retrospective study using a large database of over a million opioid naïve adults and children revealed that duration of opioid use after surgery was the strongest predictor of subsequent misuse.22 When stratified by age, the highest rate of misuse was found among 15-24 year olds. A common and valid concern is that efforts to standardize and/or decrease ORx may negatively affect patients’ postoperative experience. Yet existing data suggest otherwise. In the orthopedic literature, institutional prescribing guidelines have been shown to decrease postoperative ORx dose number without an increase in refill requests or decrease in patient satisfaction.23 Cardona-Grau et al. recently published the results of their quality improvement initiative, in which they were able to reduce the ORx dose number by 50% (to 5 doses from 10) following outpatient pediatric urologic surgery with no increase in postoperative pain scores.24 In fact, pain scores were noted to trend downwards after they implemented their reduced ORx protocol. Utilization remained the same, with a reported median of 2 doses (IQR 3.6) in both the pre- and post-intervention groups. Schröder et al. reported that only 15.3% of their patients required morphine after discharge following outpatient pediatric urologic surgery.25 In their study, patients were instructed to use scheduled acetaminophen and ibuprofen for the first 2 days and as needed thereafter, with morphine for breakthrough only. Our study similarly demonstrates a low utilization of opioids after pediatric urologic outpatient surgery, with median of 0 doses (IQR 2). One of our study goals was to identify factors associated with postoperative opioid requirement. We hypothesized that postoperative opioid use might vary with procedure type, patient age, perioperative pain control techniques, and/or 9
surgery length. Yet we did not find any of these factors to be associated with opioid use at home after surgery, as utilization was equally low among all groups. In contrast, we were able to identify factors associated with amount of opioid used intraoperatively. We found a moderate correlation between surgery length and amount of intraoperative opioid used. That is, patients undergoing longer cases generally required more intraoperative opioids, which is intuitive. Caudal blocks were associated with decreased intraoperative opioid use. This may be because all caudal blocks were routinely administered at the beginning of the case, while other blocks were often performed at the conclusion of the case. Since prescriptions were not provided for OTC medications, we questioned whether financial concerns may have contributed to parents’ decision to go straight for the prescription medication despite counseling to try OTC medications first. We found that Medicaid status was not associated with likelihood of any opioid use or with likelihood of relying solely on opioids for pain control. Overall opioid use was found to be low across all patients regardless of insurance type. Strengths of our study include its prospective nature and high response rate. A limitation of the study is the potential for underestimating medication usage due to follow up survey design. If parents did not expect to give additional medications but subsequently did so, these administrations would not have been captured. There is also the potential for inaccurate recall if parents did not record administrations in real time as instructed and instead responded to online or telephone surveys by memory. Although most patients used no opioids or very few doses after routine outpatient urologic surgery, the outliers are important to consider. Some patients likely received more doses due to parental concern/anxiety in the absence of true pain. Our data support this possibility, as some parents reported administering opioids for pain score of 0. Other patients may truly benefit from additional pain medications, whether secondary to differences in pain perception/threshold or other as yet unknown factors. Identifying these patients a priori would facilitate selective prescription of opioids, allowing for improved pain control while minimizing unused ORx. Additional research is warranted to elucidate this further. Conclusions 10
Opioid utilization is low after outpatient pediatric urologic surgery, with most patients requiring 0-2 doses regardless of procedure type or patient age. These data can be used to guide perioperative prescription-writing practices and counseling techniques, allowing surgeons to set appropriate expectations and minimize opioid overprescription without compromising pain control in our patients after surgery.
Conflict of Interest/Funding: None
Medications used
N
%
Acetaminophen only
23
14.1%
Ibuprofen only
21
12.9%
Acetaminophen + Ibuprofen
25
15.3%
Opioid* only
18
11.0%
Opioid + Ibuprofen
20
12.3%
Opioid + Acetaminophen
17
10.4%
Acetaminophen + Ibuprofen + Opioid
27
16.6%
None
12
7.4%
Total
163†
100%
Table 2: Breakdown of medication combinations taken *Opioid = hydrocodone/acetaminophen †Includes patients with complete surveys
11
Opioid used at all?
Medicaid
Other
Total
Yes
55
27
82
No
55
32
87
Total
110
59
169*
Opioid only?
Medicaid
Other
Total
Yes
11
7
18
No
95
50
145
Total
106
57
163†
P value
0.60
P value
0.71
Table 3: Medicaid status and opioid use. *Includes patients with complete surveys (N=163) and those with incomplete surveys who never filled the ORx (N=6) †Includes paƟents with complete surveys
Pain Score Medication
P value
N Min
Max
Mean
Std Dev
Median
IQR
Acetaminophen
212
0
10
3.29
2.54
3
2
Ibuprofen
184
0
10
3.93
2.63
4
4
Opioid
140
0
10
5.66
2.94
6
4
Table 4: Pain scores reported at time of medication administration
12
<0.0001
Figure 1a-c: Histogram of timing of last dose of each medication in post-operative days.
13
Figure 1d: Histogram of total number of postoperative opioid doses given.
14
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Pardo B. Do more robust prescription drug monitoring programs reduce prescription opioid overdose? Addiction. 2017;112(10):1773-1783.
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Tsze DS, von Baeyer CL, Bulloch B, Dayan PS. Validation of self-report pain scales in children. Pediatrics. 2013;132(4):e971-979.
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Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001;93(2):173-183.
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Chiu AS, Healy JM, DeWane MP, Longo WE, Yoo PS. Trainees as Agents of Change in the Opioid Epidemic: Optimizing the Opioid Prescription Practices of Surgical Residents. J Surg Educ. 2018;75(1):65-71.
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Olsen KR, Hall DJ, Mira JC, et al. Postoperative surgical trainee opioid prescribing practices (POST OPP): an institutional study. J Surg Res. 2018;229:58-65.
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Denning NL, Kvasnovsky C, Golden JM, Rich BS, Lipskar AM. Inconsistency in Opioid Prescribing Practices After Pediatric Ambulatory Hernia Surgery. J Surg Res. 2019;241:57-62.
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Womer J, Zhong W, Kraemer FW, et al. Variation of opioid use in pediatric inpatients across hospitals in the U.S. J Pain Symptom Manage. 2014;48(5):903-914.
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Morrison K, Herbst K, Corbett S, Herndon CD. Pain management practice patterns for common pediatric urology procedures. Urology. 2014;83(1):206-210.
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Brummett CM, Waljee JF, Goesling J, et al. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017;152(6):e170504.
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Brat GA, Agniel D, Beam A, et al. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018;360:j5790.
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17
S1477-5131(19)30341-9
DOI:
https://doi.org/10.1016/j.jpurol.2019.10.021
Reference:
JPUROL 3305
To appear in:
Journal of Pediatric Urology
Received Date: 23 July 2019 Accepted Date: 23 October 2019
Please cite this article as: Bilgutay AN, Hua H, Edmond M, Blum ES, Smith EA, Elmore JM, Scherz HC, Garcia-Roig M, Kirsch AJ, Cerwinka WH, Opioid Utilization is Minimal after Outpatient Pediatric Urologic Surgery, Journal of Pediatric Urology, https://doi.org/10.1016/j.jpurol.2019.10.021. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.
Opioid Utilization is Minimal after Outpatient Pediatric Urologic Surgery Aylin N. Bilgutay,1,2 Hannah Hua,3 Mary Edmond,3 Emily S. Blum,1,2,4 Edwin A. Smith,1,2 James M. Elmore,1,2 Hal C. Scherz,1,2 Michael Garcia-Roig,1,2 Andrew J. Kirsch,1,2 Wolfgang H. Cerwinka,1,2 1
Children’s Healthcare of Atlanta, Atlanta, GA, Department of Pediatric Urology Emory University, Atlanta, GA, Department of Pediatric Urology 3 Children’s Healthcare of Atlanta, Atlanta, GA, Department of Statistics, Advanced Analytics Team 4 Global Center for Medical Innovation, Atlanta, GA 2
Corresponding author Aylin N Bilgutay Address: 5730 Glenridge Drive, Suite 200, Sandy Springs, GA 30328 Telephone: (404) 252-5206 Fax: (404) 252-1268 Email: [email protected]
Key Words: Opioid, population health, postoperative pain, prospective
Abstract/Extended Summary Introduction: There are no guidelines for opioid use after pediatric urologic surgery, and it is unknown to what extent prescriptions written for these patients may be contributing to the opioid epidemic in the United States. We sought to characterize opioid utilization in a prospective fashion following outpatient pediatric urologic surgery at our institution.
Materials and Methods: After obtaining IRB approval, we prospectively recruited pediatric patients undergoing outpatient urologic surgery. All patients and families were counseled regarding appropriate use of over-the-counter pain medications as first-line agents, with opioids for breakthrough pain only. All patients received an opioid prescription (ORx), which we attempted to standardize to 10 doses. Parents were provided with a log for keeping track of pain medication administration. Postoperative surveys were sent at various time-points after surgery to assess utilization of pain medications at home. We quantified unused opioids prescribed and evaluated factors potentially associated with opioid use.
Results: Two hundred and two patients were recruited. All patients were male, with a median age of 2.7 years (IQR 5.5, range 0.5-17.9 years). One hundred and fifty-four children underwent penile surgery, 22 underwent scrotal surgery, and 27 underwent inguinal surgery. Nearly half of our study patients were black, 33.2% were white, 12.9% were Latino, and 4.0% were Asian. The median number of doses prescribed was 10 (IQR 0, range 4.0-20.8). Postoperative surveys were completed by 80.7% of study patients. The median number of opioid doses used was 0 (IQR 2), while the mean was 1.28 (SD 1.98). None of the factors evaluated (including patient age, surgery type, perioperative pain management techniques, length of surgery, and insurance type) were associated with amount of opioid used at home after surgery, as utilization was equally low across all groups.
Discussion and Conclusions: Ensuring adequate postoperative pain control for children is critical, yet it is also important to minimize excess ORx. We found that the majority of pediatric patients used 0-2 doses of prescription pain medication after discharge following outpatient urologic surgery, representing a small percentage of the total prescribed amount. Low utilization was seen irrespective of patient age, procedure, and perioperative factors. These data can be used to 1
guide perioperative patient and family counseling and to guide future efforts to standardize ORx following outpatient pediatric urologic surgery.
Postop Opioid Doses Procedure Type N = 169* Mean (Range, Std Dev) Median (IQR) P value Penile 132 1.31 (0-11, 2.03) 0 (2) 0.78 Inguinal 20 1 (0-5, 1.41) 0.5 (1.5) Scrotal 17 1.41 (0-8, 2.24) 0 (2) Age (Years) N = 169* Mean (Range, Std Dev) Median (IQR) P value <1 37 1.41 (0-7, 1.86) 1 (2) 0.82 1 to < 3 52 1.17 (0-5, 1.65) 0 (2) 3-10 55 1.18 (0-11, 2.22) 0 (2) > 10 25 1.56 (0-8, 2.29) 0 (3) Table 1: Number of postoperative opioid doses by procedure type and age group *Includes patients with complete surveys (N=163) and those with incomplete surveys who never filled the ORx (N=6)
Introduction Due to their narrow therapeutic index, addictive nature, and potential for serious or even life-threatening consequences of abuse and overdose, opioid prescriptions are tightly regulated in the United States (US) at both the state and federal level.1 Yet in spite of these measures, the US is facing an opioid crisis that has been fueled in part by prescription drugs. Over 42,000 people died from opioid overdose in the US in 2016; 40% of those deaths involved a prescription medication.2 New regulations have been implemented in several states in response to the epidemic. Georgia has recently instituted a Prescription Drug Monitoring Program (PDMP) to track all opioid prescriptions filled in the state, with the goal of decreasing the potential for abuse. All opioid prescribers in Georgia are required to register with the PDMP, and dispensers must enter information within 24 hours of filling a prescription.3 Similar programs have been successful in other states. In Florida, oxycodone-caused mortality declined abruptly in 2011 after a PDMP was established.4 A recent study comparing data across all 50 states and the District of Columbia from 1999-2014 found that more robust PDMPs were associated with fewer prescription opioid overdose deaths.5
Overprescription of postoperative opioid has been reported in the adult urologic literature. Bates et al. found that 67% of the patients in their study had remaining opioids following urologic surgery. Ninety-two percent had not received any instruction for its disposal, and 91% kept the surplus medication in the home.6 Pediatric specialists may also prescribe 2
more opioid than needed. In their 2017 survey-based study including 343 pediatric inpatients (98% postoperative), Monitto et al. reported that 58% of prescribed opioid doses were not consumed.7 Only 19% of families were instructed regarding how to dispose of remaining opioids, and an even smaller minority (4%) actually did so. We hypothesized that opioids are overprescribed after outpatient pediatric urologic surgery. The aims of our study were to quantify postoperative pain and to determine the requirement for analgesics, and specifically the utilization of opioids, in this patient population.
Materials and Methods After obtaining IRB approval, we recruited pediatric patients undergoing outpatient urologic surgery at our institution between August 2018 and April 2019. A power analysis using a standard power of 0.8 revealed that a sample size of 116 patients would be required to show a 25% difference in proportion of opioid used between groups. We therefore set a goal to recruit 200 patients, taking into consideration that our response rate would not be 100% and that the expected true difference (if any) was unknown and possibly smaller than hypothesized. Patients aged 6 months to 18 years undergoing outpatient urologic surgery by one of 7 attendings or 1 junior attending were eligible. Informed consent was obtained from the parent or legal guardian of each patient. In accordance with IRB policies, age-appropriate written or verbal assent was obtained from all patients ≥ 5 years old. Demographic, preoperative, and intraoperative data were prospectively collected. We noted use of opioid or nonopioid premedications, use of caudal or other blocks, surgery length, quantity of intraoperative opioids used, use of ketorolac, and quantity of opioids given in the post-anesthetic care unit. All perioperative opioids were converted to oral morphine milligram equivalents per patient kilogram (MME/kg).
Parents of children <4 years old were counseled regarding pain assessment using the Face Legs Activity Cry Consolability (FLACC) pain scale. Parents of children ≥4 years old were counseled regarding pain assessment using the Faces Pain Scale, Revised (FPS-R). Both tools are validated for pain assessment in the pediatric population with a scale from 0-10.8-11 Parents were instructed to use acetaminophen and/or ibuprofen as needed for pain, and were given detailed written dosing information including concentration, volume, and frequency, with dose calculated based on their child’s weight 3
(10 mg/kg). Parents were informed that they could give each over-the-counter (OTC) medication every 4-6 hours prn, so that if alternated, the child could receive a non-opioid pain medication every 2-3 hours if needed. All parents also received an opioid prescription (hydrocodone-acetaminophen dosed at 0.1 mg/kg, appropriately formulated based on patient weight and ability to swallow pills), which they were instructed to use for breakthrough only. We chose this postoperative pain management regimen (OTC medications prn as first-line agents with opioid-acetaminophen combination for breakthrough) based on our usual practice patterns. Prior to study initiation, all patients ≥ 6 months old typically received an ORx; however, there was significant variation in the number of doses, with 10-20 doses routinely being prescribed. We therefore attempted to standardize postop ORx to 10 doses per study patient. Parents were counseled regarding the risk of acetaminophen toxicity and were instructed to wait at least 6 hours between doses of any acetaminophen-containing medications. Instructions were given regarding safe storage and disposal of unused opioids.
Parents were given a blank log to fill in pertinent information about any pain medication given in real-time, including name of drug, date/time of administration, and associated pain score. Study data were subsequently collected and managed with the Research Electronic Data Capture (REDCap) system. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.12,13
Links to online REDCap surveys were emailed to parents starting 24 hours after surgery, asking whether the child had taken any acetaminophen or ibuprofen. If they answered ‘yes’ for either medication, they were prompted to fill in the number of doses given, date/time of each dose, and associated pain score. They were also asked whether they had filled the ORx. If so, they were asked whether the patient had received any prescription medication, and if so, how many doses, date/time of each dose, and associated pain score. The final question was whether they anticipated giving additional pain medications. If they answered ‘yes,’ then additional surveys were sent out 1-2 days later, allowing the 4
parent to complete up to 10 postoperative surveys. If the initial or follow-up surveys were not completed within 48 hours, up to 5 reminder emails were sent. Parents were called by telephone in an attempt to obtain the above information if they did not have access to email, preferred not to give their email address, or if they did not fill out the emailed survey after 5 reminders. PDMP query allowed us to determine whether the ORx had been filled for those patients whose parents did not fill out email surveys and who were unable to be reached by telephone.
The data were analyzed for evidence of association between postoperative opioid doses and patient age, surgery type/length, and perioperative pain management techniques. Statistical analysis was conducted in SAS Enterprise Guide 7.1 (SAS Institute., Cary, NC, USA). Analyses were two-sided, with p values < 0.05 considered statistically significant. Pearson’s correlation coefficient was obtained to assess for correlation between surgery length and quantity of intraoperative and/or postoperative opioid administered. T tests were applied to evaluate for association between postop opioid doses and preop treatments, such as presence of caudal block, and for association between postop opioid doses and patient balanitis xerotica obliterans (BXO) status. Chi-square tests were implemented to analyze the relationship between opioid use and Medicaid status. One-way ANOVA was used to compare pain scores reported at time of administration for the three different pain drugs. To test if postop opioid doses were related to age, patients were divided into four age groups (< 1 year old, 1-3, 3-10, and > 10 years old). One-way ANOVA was then used to compare the postop opioid doses among these four age groups. To evaluate whether postop opioid doses varied with procedure type, patients were divided into three groups based on incision location (penile, inguinal, or scrotal); one-way ANOVA was used to compare the postop opioid doses between these groups.
Results Two hundred and two patients were recruited. Although not mandated by study design, all of the participants were male. Patient age at time of surgery ranged from 0.5 to 17.9 years (median 2.7, IQR 5.5). Nearly half of the patients were black (49.5%), 33.2% white, 12.9% Latino, 4.0% Asian.
5
Patients underwent a variety of surgeries, including circumcision (94), circumcision revision (30), scrotal orchiopexy (20), inguinal orchiopexy (14), division of penile bands (12), inguinal hernia repair (11), meatoplasty (8), phalloplasty (6), hypospadias repair (3), inguinal orchiectomy (1), scrotal orchiectomy (1), scrotal hydrocele (1), and excision of penile lesion (1). For analysis, the procedures were grouped according to incision location, with 154 penile (76.2%), 26 inguinal (12.9%), and 22 scrotal (10.9%). Sixty-six percent of the study patients were insured by Medicaid.
Thirty-four percent of patients received an oral opioid premedication in the preoperative holding area with a median dose of 0.13 MME/kg (IQR 0.04), while 61.9% received a nonopioid premedication consisting of acetaminophen, midazolam, or both. Fifty-seven percent of patients underwent caudal block, while 39.6% received other block types (penile or cord, depending on surgical site) and/or peri-incisional local. Thirty-three percent of patients received intravenous ketorolac intraoperatively. The median total intraoperative opioid received was 0.16 MME/kg (IQR 0.11, range 0-0.51).
Of 78 patients in the FPS-R group, 63 (80.8%) completed surveys as requested (i.e. until no additional medication administration was anticipated). Three FPS-R patients without responses did not fill their ORx, and we were therefore able to deduce that no opioid was used by those patients. One hundred of 124 FLACC group patients (80.6%) completed surveys as requested. Three FLACC patients without responses did not fill their ORx, and we were therefore able to deduce that no opioid was used. The maximum number of surveys completed for a single patient was 4. Three families completed at least one survey, but indicated that additional pain medications were anticipated then did not complete follow-up surveys as requested. The data for these patients were considered incomplete and were not included in the analysis.
The median number of opioid doses prescribed was 10 (IQR 0, range 4.0-20.8), while the median number of opioid doses used was 0 (IQR 2, range 0-11). The mean number of opioid doses used was 1.28 (SD 1.98). No difference in amount of opioid used was seen based on procedure type or patient age (Table 1). The median number of excess doses prescribed per patient was 10 (IQR 2). 6
Despite being counseled to try both acetaminophen and ibuprofen before resorting to the ORx, 11.0% used the ORx for pain control without trying either OTC medication. An additional 22.7% used an opioid and only one OTC medication. Seven percent used no pain medication of any kind. The complete breakdown of medication use is shown in Table 2.
Fifty-six percent of the patients who completed surveys reported acetaminophen use. The median number of acetaminophen doses given was 1 (IQR 3). For those who gave any acetaminophen, the median number of doses was 3 (IQR 4). Fifty-seven percent of patients reported ibuprofen use. The median number of ibuprofen doses given was 1 (IQR 3). For those who gave any ibuprofen, the median dose number was 3 (IQR 3). Fifty percent of patients who completed surveys (82/163) reported opioid use. When taking into account 6 additional patients who did not complete surveys but never filled the script, we know that only 48.5% (82/169) used opioid. Overall, the median number of opioid doses given was 0 (IQR 2). For those who gave any opioid at all, median dose number was 2 (IQR 3).
Patients received ibuprofen and acetaminophen for a median of 2 days (IQR 2) and opioid for a median of 2 (IQR 3) days. Some patients received analgesics longer, up to a maximum of 10 days for acetaminophen, 7 days for ibuprofen, and 6 days for opioid (Figure 1a-c).
Medicaid status was not associated with likelihood of using any opioids (p=0.60) or only opioids (p=0.71) for postoperative pain control at home (Table 3). Perioperative factors, including use of opioid or non-opioid premedication, use of caudal or other block, use of intraoperative ketorolac, and length of surgery were not associated with number of opioid doses or amount of opioid in MME/kg used postoperatively. A moderate positive linear relationship was found between surgery length and quantity of intraoperative opioids used (Pearson correlation coefficient 0.35, p<0.0001). The presence of a caudal block was associated with decreased intraoperative opioid use compared to other blocks such as penile or cord blocks (mean 0.13 MME/kg for those with caudal block versus mean 0.23 MME/kg for those with other blocks; p<0.0001).
7
Pain scores at time of medication administration ranged from 0-10 for all three medications. Yet overall, pain scores recorded at time of opioid provision were significantly higher than pain scores at time of OTC medication administration (p<0.0001; Table 4).
Seventy-six percent of patients filled their ORx. Likelihood of filling the scripts did not vary with patient age or with procedure type.
While the majority of patients used no opioids or very few doses, it is worth noting the presence of outliers skewing the data to the right, up to a maximum of 11 doses (Figure 1d). The maximum number of postoperative opioid doses was recorded after a circumcision in a patient with BXO. The second highest number of opioid doses recorded was 9 after a circumcision in a patient without BXO. There were only 4 BXO patients in our cohort – the other 3 required 0, 1, and 5 doses each. Although the mean (4.25 vs 1.37) and median (3 vs 0) number of opioid doses after circumcision was higher in patients with BXO compared to those without, we were unable to show statistical significance (p=0.33) due to the small number of BXO patients. Only one patient in the entire cohort (0.5%) required additional opioids beyond what was initially prescribed. That patient had undergone hypospadias repair with a catheter in place and also required a refill of oxybutynin.
Discussion Although pain control is an important part of postoperative patient care, the existing medical literature indicates a lack of formal training for surgical trainees on this topic. A recent survey of Canadian chief urology residents found that nearly three-quarters of respondents had received most of their pain management education from other trainees.14 In the same study, most respondents agreed or strongly agreed that formalized education on this subject would have been beneficial. A 2018 survey of general surgery residents at a tertiary academic center in the US revealed that >90% of respondents had not been formally educated regarding opioid prescription best practices or pain management in general.15
8
Lack of formal education may contribute to observed variability in practice patterns. In 2018, Eid et al. reported variability in outpatient ORx after the same type of surgery at a single academic center.16 Other authors have similarly reported variable postoperative ORx practices among surgeons and surgical trainees.17,18 Variation in opioid use has also been reported among pediatric inpatients at different hospitals in the US.19 Morrison et al. published a survey of members of the Societies for Pediatric Urology in 2014, which revealed no consensus in perioperative and postoperative pain management techniques after common pediatric urologic procedures.20 Postsurgical prescriptions have been associated with overdose and misuse. Brummet et al. reported the incidence of new, persistent opioid use in US adults to be similar after major or minor surgery, ranging from 5.9-6.5%, while the incidence in a nonoperative control group was only 0.4%.21 A recent retrospective study using a large database of over a million opioid naïve adults and children revealed that duration of opioid use after surgery was the strongest predictor of subsequent misuse.22 When stratified by age, the highest rate of misuse was found among 15-24 year olds. A common and valid concern is that efforts to standardize and/or decrease ORx may negatively affect patients’ postoperative experience. Yet existing data suggest otherwise. In the orthopedic literature, institutional prescribing guidelines have been shown to decrease postoperative ORx dose number without an increase in refill requests or decrease in patient satisfaction.23 Cardona-Grau et al. recently published the results of their quality improvement initiative, in which they were able to reduce the ORx dose number by 50% (to 5 doses from 10) following outpatient pediatric urologic surgery with no increase in postoperative pain scores.24 In fact, pain scores were noted to trend downwards after they implemented their reduced ORx protocol. Utilization remained the same, with a reported median of 2 doses (IQR 3.6) in both the pre- and post-intervention groups. Schröder et al. reported that only 15.3% of their patients required morphine after discharge following outpatient pediatric urologic surgery.25 In their study, patients were instructed to use scheduled acetaminophen and ibuprofen for the first 2 days and as needed thereafter, with morphine for breakthrough only. Our study similarly demonstrates a low utilization of opioids after pediatric urologic outpatient surgery, with median of 0 doses (IQR 2). One of our study goals was to identify factors associated with postoperative opioid requirement. We hypothesized that postoperative opioid use might vary with procedure type, patient age, perioperative pain control techniques, and/or 9
surgery length. Yet we did not find any of these factors to be associated with opioid use at home after surgery, as utilization was equally low among all groups. In contrast, we were able to identify factors associated with amount of opioid used intraoperatively. We found a moderate correlation between surgery length and amount of intraoperative opioid used. That is, patients undergoing longer cases generally required more intraoperative opioids, which is intuitive. Caudal blocks were associated with decreased intraoperative opioid use. This may be because all caudal blocks were routinely administered at the beginning of the case, while other blocks were often performed at the conclusion of the case. Since prescriptions were not provided for OTC medications, we questioned whether financial concerns may have contributed to parents’ decision to go straight for the prescription medication despite counseling to try OTC medications first. We found that Medicaid status was not associated with likelihood of any opioid use or with likelihood of relying solely on opioids for pain control. Overall opioid use was found to be low across all patients regardless of insurance type. Strengths of our study include its prospective nature and high response rate. A limitation of the study is the potential for underestimating medication usage due to follow up survey design. If parents did not expect to give additional medications but subsequently did so, these administrations would not have been captured. There is also the potential for inaccurate recall if parents did not record administrations in real time as instructed and instead responded to online or telephone surveys by memory. Although most patients used no opioids or very few doses after routine outpatient urologic surgery, the outliers are important to consider. Some patients likely received more doses due to parental concern/anxiety in the absence of true pain. Our data support this possibility, as some parents reported administering opioids for pain score of 0. Other patients may truly benefit from additional pain medications, whether secondary to differences in pain perception/threshold or other as yet unknown factors. Identifying these patients a priori would facilitate selective prescription of opioids, allowing for improved pain control while minimizing unused ORx. Additional research is warranted to elucidate this further. Conclusions 10
Opioid utilization is low after outpatient pediatric urologic surgery, with most patients requiring 0-2 doses regardless of procedure type or patient age. These data can be used to guide perioperative prescription-writing practices and counseling techniques, allowing surgeons to set appropriate expectations and minimize opioid overprescription without compromising pain control in our patients after surgery.
Conflict of Interest/Funding: None
Medications used
N
%
Acetaminophen only
23
14.1%
Ibuprofen only
21
12.9%
Acetaminophen + Ibuprofen
25
15.3%
Opioid* only
18
11.0%
Opioid + Ibuprofen
20
12.3%
Opioid + Acetaminophen
17
10.4%
Acetaminophen + Ibuprofen + Opioid
27
16.6%
None
12
7.4%
Total
163†
100%
Table 2: Breakdown of medication combinations taken *Opioid = hydrocodone/acetaminophen †Includes patients with complete surveys
11
Opioid used at all?
Medicaid
Other
Total
Yes
55
27
82
No
55
32
87
Total
110
59
169*
Opioid only?
Medicaid
Other
Total
Yes
11
7
18
No
95
50
145
Total
106
57
163†
P value
0.60
P value
0.71
Table 3: Medicaid status and opioid use. *Includes patients with complete surveys (N=163) and those with incomplete surveys who never filled the ORx (N=6) †Includes paƟents with complete surveys
Pain Score Medication
P value
N Min
Max
Mean
Std Dev
Median
IQR
Acetaminophen
212
0
10
3.29
2.54
3
2
Ibuprofen
184
0
10
3.93
2.63
4
4
Opioid
140
0
10
5.66
2.94
6
4
Table 4: Pain scores reported at time of medication administration
12
<0.0001
Figure 1a-c: Histogram of timing of last dose of each medication in post-operative days.
13
Figure 1d: Histogram of total number of postoperative opioid doses given.
14
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17