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Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy
G Model
PEDOT-7787; No. of Pages 4 International Journal of Pediatric Otorhinolaryngology xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy B. Oremule *, M. Johnson, L. Sanderson, J. Lutz, J. Dodd, P. Hans Blackpool Teaching Hospitals NHS Trust, Blackpool, UK
A R T I C L E I N F O
A B S T R A C T
Article history: Received 24 May 2015 Received in revised form 24 September 2015 Accepted 30 September 2015 Available online xxx
Objectives: The withdrawal of codeine for use in children following tonsillectomy enforced a change in our practice of providing regular paracetamol and ibuprofen, with codeine for breakthrough pain relief. Our objectives were to; examine the effectiveness of paracetamol and ibuprofen; examine the effectiveness of the addition of rescue (PRN) morphine to regular paracetamol and ibuprofen. Methods: A 2 cycle prospective audit was conducted on our unit. Telephone consultations were conducted with parents of 74 children undergoing tonsillectomy and adenotonsillectomy. Cycle 1 (C1, without morphine) contained 24 consecutive patients and cycle 2 (C2, with morphine) contained 50 consecutive patients. Postoperative health service contact and outcome was recorded: worst pain scores on days 4 and 7 were obtained using validated pain assessment tools scoring 0–10. Cycle 2 results underwent subgroup analysis by method of surgery i.e. coblation (C2C) and cold steel dissection (C2D) groups. Results: More than half of parents felt simple analgesia was not effective enough in both cycles, this number was significantly higher in both 2nd cycle groups (C1 = 54%, C2C = 74%, p = 0.003, C2D = 84%, p = 0.0001). Mean worst pain reported at day 4 was similar for all groups, but the morphine groups reported higher pain at day 7 (C1 1.6, C2C 3.59, p = 0.017, C2D 3.90, p = 0.002). Antibiotic prescribing for children contacting a GP after surgery was significantly lower in the morphine groups (C1 24%, C2C 7%, p = 0.0014, C2D 5%, p = 0.0002). There was no difference in measured outcomes between the 2nd cycle groups. Conclusion: This service evaluation found that postoperative morphine on an as-required basis, in addition to regular paracetamol and ibuprofen, did not significantly alter initial pain profile, worst pain scores or rate of health service contact when compared to regular paracetamol and ibuprofen alone. The majority of children in this study felt additional analgesia required. Children in the morphine groups experienced significantly less pharmacological intervention when contacting the GP after surgery. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Paediatric Adenotonsillectomy Tonsillectomy Pain management Morphine
1. Introduction In 2012 there were 18,000 tonsillectomy operations performed on children in the National Health Service in England [1]. For an operation so widely performed mortality from tonsillectomy is low. A prospective audit of 33,921 tonsillectomies in England and Northern Ireland reported 1 death [2]. Despite the frequency of its performance, tonsillectomy is associated with significant morbidity. Postoperative complications include pain, bleeding, infection, postoperative nausea and vomiting (PONV) and sleep-disordered breathing [3]. A study in the United States including over 36,000
* Corresponding author. Tel.: +44 1253300000. E-mail address: [email protected] (B. Oremule).
children looked at 1st and 2nd revisit rates within 14 days amongst children undergoing tonsillectomy or adenotonsillectomy and found acute pain was the primary diagnosis in 18.4% and 11.2% respectively [4]. Acute pain causes fear, anxiety, distress and behavioural changes in children following surgery [5]. Pain following tonsillectomy is associated with decreased oral intake, dehydration, and latency in recovery after surgery [6]. Typically pain surges on postoperative day 4 or 5 before improving on day 6 [7,8]. Gauging analgesic requirements in this age group is problematic as younger age groups are unable to accurately communicate the amount of pain they are feeling. Routine practice in the United Kingdom sees the majority of children undergoing tonsillectomy looked after at home by parents or carers after the procedure and adds a layer of complexity in the management of the child’s postoperative pain.
http://dx.doi.org/10.1016/j.ijporl.2015.09.040 0165-5876/ß 2015 Elsevier Ireland Ltd. All rights reserved.
Please cite this article in press as: B. Oremule, et al., Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy, Int. J. Pediatr. Otorhinolaryngol. (2015), http://dx.doi.org/10.1016/j.ijporl.2015.09.040
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PEDOT-7787; No. of Pages 4 B. Oremule et al. / International Journal of Pediatric Otorhinolaryngology xxx (2015) xxx–xxx
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1.1. Pain management quandary Kelly et al. [9] documented fatalities in children in North America due to postoperative codeine administration. Following these findings, the United States Federal Drug Agency placed a boxed warning and contraindication on codeine following tonsillectomy and adenotonsillectomy in children in 2013 and the Medicines and Healthcare Products Regulatory Agency (MHRA) closely followed suit [10,11]. A consensus on an alternative is yet to be agreed. At our hospital, we previously used a combination of paracetamol, ibuprofen and codeine for postoperative take-home analgesia. The prescription of codeine was stopped after the MHRA warning, and parents were advised to continue with regular paracetamol and ibuprofen. We wanted to assess the adequacy of this reduced analgesic regime, and provide an appropriate alternative breakthrough analgesic if it was found not to be adequate. 1.2. Aims Our aims were to: 1. Assess adequacy of postoperative paracetamol and ibuprofen alone. 2. Assess postoperative pain management following implementation of discharging patients with as-required (PRN) oral morphine. 3. Reduce health service contact attendance due to postoperative pain.
2. Method We undertook service evaluation by completing a prospective 2 cycle departmental audit on our paediatric tonsillectomy patients. Our Research and Development department deemed ethical approval not necessary for this study. In the first cycle, all children undergoing tonsillectomy and adenotonsillectomy were included (ages 1> to <16 years). Children <1 year or undergoing concomitant grommet insertion were excluded. Parents were asked to give their children regular ibuprofen three times daily, with meals, with regular paracetamol between ibuprofen doses. 24 consecutive patients from February 2014 to May 2014 were selected. Patients/carers were contacted on day 4 and day 7 post-operatively. They were asked whether additional analgesia was required (aside from paracetamol and ibuprofen), about worst pain scores and whether healthcare services were contacted, and if so what the outcome was. The inclusion and exclusion criteria were unchanged for the second cycle. Second cycle patients were provided with four day’s supply of oral morphine to be used for breakthrough pain relief. Morphine was dosed according to weight and age–at a reduced dose compared to doses published in the British National Formulary (BNF). This action was based on guidelines provided by Alder Hey Children’s Hospital (Appendix A). 50 consecutive patients from September 2014 to February 2015 were selected. Patients/carers were asked whether additional analgesia required (other than paracetamol and ibuprofen), about worst pain scores at day 4 and day 7, what day post-operatively did parents give morphine, whether healthcare services were contacted, and if so what the outcome was. All patients and their carers were given oral and written information designed at a local level at discharge, including the expected pain profile and safe administration of analgesia. The pain assessment tool used depended on the age and understanding of the child [12–14].
Analysis of the morphine group was subdivided into coblation and cold steel dissection groups to attempt to mitigate method of surgery as a confounding factor. Cold steel dissection tends to be carried out by junior surgical trainees at our hospital and this could possibly skew the results. Statistical analysis was carried out using SPSSTM Ver. 20.
3. Results In the 1st cycle the mean age of the children was 7.3 years (median 5.5, range 3–14 years, SD 3.86) (Table 1). Coblation tonsillectomy was used in all 24 children. 13/24 (54%) felt that additional analgesia was required. The mean worst pain score reported on day 4 was 4.98, 95% CI 3.35–6.6 (median 6, SD 3.86). This dropped to a mean score of 1.6 on day 7, 95% CI 0.79–2.41 (median 1, SD 1.92). The GP was contacted in the cases of 9 children (36%) children, 6 (24%) of whom were given antibiotics, 1 given difflam, another given PRN analgesia and the last had no outcome recorded. 1 child was re-admitted to ward on postoperative day 5 and given IV fluids. One of the patients given antibiotics was also given codeine by the GP. In the 2nd cycle the overall mean age of the children was 6.2 years (median 5, range 2–15 years, SD 2.9). Coblation tonsillectomy was used in 28 children, cold steel dissection in 19 and 3 operation methods were unrecorded. GP or walk-in centre contact was made for 9 (36%) children; 5 were given antibiotics and 4 were given advice. 1 child was re-admitted to the wards for intravenous fluid therapy on the second postoperative day. In the coblation group, the mean age of the children was 6.54 years (median 5, range 2–15 years, SD 3.43). 21/28 patients (75%) felt additional analgesia was required and all 21 used the morphine provided. Mean pain score reported after 4 days was 6.30, 95% CI 5.6–7 (range 2–10, SD 1.81). By day 7 this had dropped to 3.59, 95% CI 2.52–4.64 (range 0–10, SD 2.73). In those that used morphine, it was used on average at 3.33 days (SD 1.56) and for 2.52 days (range = 1–4, SD 1.17 days). 10/28 (36%) attended or contacted their GP, walk-in centre (WIC) or emergency department. Of these children, 7 were given advice, 2 antibiotics and 1 difflam. 3 children were re-admitted; 2 for intravenous fluids and 1 was returned to theatre due to a postoperative bleed. The dissection group contained 19 children; their mean age was 6.47 years (median 5, range 2–14, SD 3.67). 16/19 (84%) felt additional analgesia was required they all used the provided morphine; those that did not refrained from morphine use. On day 4 the mean pain score reported was 6.82, 95% CI 5.56–8.08 (range 1– 10, SD 2.62). By day 7 this had dropped to 3.90, 95% CI 2.87–4.93 (range 0–8, SD 2.13). 6/19 (32%) attended the GP, WIC or emergency department and 2 further children were re-admitted to the ward. Of the 6, 5 were given advice and 1 given antibiotics. In those children using morphine, the mean timing of first use was 3.56 days, 95% CI 2.84–4.29 (median, 4 range 1–6, SD 1.36) and it Table 1 Comparison of outcomes between Cycle 1 and Cycle 2 coblation groups.
Mean age (years) Needed additional analgesia Mean worst pain score day 4 Mean worst pain score day 7 Saw pain score reduce from day 4 to day 7 Attended GP or WIC Given antibiotic Re-admitted to ward
Cycle 1 (n = 24)
Cycle 2 Coblation (n = 28)
p-value
7.27 54% 4.98 1.60 79%
6.54 75% 6.30 3.59 82%
0.328 0.003 0.154 0.017 0.7215
36% 24% 4%
36% 7% 11%
1.0000 0.0014 0.1046
Please cite this article in press as: B. Oremule, et al., Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy, Int. J. Pediatr. Otorhinolaryngol. (2015), http://dx.doi.org/10.1016/j.ijporl.2015.09.040
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was used for an average of 2.94 days, 95% CI 1.92–3.96 (median 3, range 1–6, SD 1.91). 1 patient suffered from abdominal discomfort following liquid morphine, no other adverse effects were noted. Despite the fact codeine is listed as a contraindication in post-tonsillectomy and adenotonsillectomy in the British National Formulary for Children, one 11-year-old child was given codeine postoperatively by their GP in the first cycle. Data were not fully recorded for 3 patients and they were excluded from the analysis. 4. Discussion Regular simple analgesics i.e. paracetamol and non-steroidal anti-inflammatory drugs (NSAIDS) reduce postoperative pain and when used in combination reduce the amount needed of each drug [15]. The administration of a single intraoperative dose of steroid can reduce postoperative pain and has the added benefit of reducing PONV [16]. Other remedies such as honey and various mouthwashes and sprays have been tried with limited evidence of their efficacy [17,18]. More recently perioperative acupuncture has been studied specifically for its effect on postoperative pain in the paediatric population [19]. Despite regular use of simple analgesia breakthrough pain can still occur, requiring an opioid such as morphine or oxycodone. The rationale behind using morphine at our institution was that unlike codeine the surgical team could more reliably predict the pharmacokinetics of the drug, with the aim of providing adequate analgesia whilst preventing excessive respiratory depression. 4.1. Effect on postoperative pain More than half the children and carers in both groups felt that additional analgesia was required (Tables 1 and 2), indicating that the combination of regular paracetamol and ibuprofen, though effective, is not enough for the majority of children undergoing tonsillectomy. This feeling was significantly higher in the morphine group, both in the coblation and cold steel dissection arms. The authors postulate that the mere fact that morphine was given to the second group may have raised their expectations of postoperative pain and were therefore more likely to report it hence the higher mean worst pain scores seen in that group. Morphine was used on average on the 3rd postoperative day, slightly earlier than the expected surge in postoperative pain around the 4th postoperative day, but it did not appear to have a benefit in either delaying the surge of pain or dampening the pain felt on day 4, with similar pain scores reported for day 4 in all groups. There was no difference in the number that saw their pain reduce between postoperative days 4 and 7. Interestingly, children in the morphine group reported significantly higher pain scores on the 7th postoperative day, in both the coblation and dissection groups. We used significantly lower doses than recommended in the BNF (0.15 mg/kg); perhaps the doses Table 2 Comparison of outcomes between Cycle 1 and Cycle 2 dissection groups.
Mean age (years) Needed additional analgesia Mean worst pain score day 4 Mean worst pain score day 7 Saw pain score reduce from day 4 to day 7 Given antibiotic Attended GP or WIC Re-admitted to ward
Cycle 1 (n = 24)
Cycle 2 (dissection) (n = 19)
p-value
7.27 54% 4.98 1.60 79%
6.47 84% 6.82 3.90 84%
0.383 0.0001 0.891 0.002 0.4667
24% 36% 4%
5% 32% 11%
0.0002 0.6545 0.1046
3
Table 3 Comparison of outcomes between Cycle 2 coblation and dissection groups. Cycle 2 (coblation) Cycle 2 (dissection) p-value (n = 28) (n = 19) Mean age (years) Needed additional analgesia Mean worst pain score day 4 Mean worst pain score day 7 Saw pain score reduce from day 4 to day 7 Attended GP or WIC Given antibiotic Re-admitted to ward
6.54 75% 6.30 3.59 82%
6.47 84% 6.82 3.90 84%
0.9471 0.1606 0.4245 0.6794 0.8409
36% 7% 11%
32% 5% 11%
0.6545 0.7673 1.0000
were too low to combat the expectation levels of the parents and children. The authors were wary of the dangerous possibility of respiratory depression in this group of patients. We were mindful that Kelly et al. [20] showed the risk of respiratory depression is real, even at recommended doses. 4.2. Other effects Morphine did not appear to confer any benefit in the reduction of overall postoperative GP, WIC, emergency department attendance or re-admission. However, of note, there was a highly statistically significant drop in the number of patients prescribed postoperative antibiotics. One hypothesis to explain this occurrence is that in the second cycle, where patients already had morphine, GPs felt more comfortable telling them to use the morphine for the pain and not resort to antibiotics as a means of helping with pain. 4.3. Coblation versus cold-steel dissection There were no significant differences in measured outcomes between the coblation and dissection groups (Table 3). Our results concur with a recent Cochrane review that did not find sufficient evidence to find coblation better or worse for postoperative pain or speed and safety of recovery than other surgical techniques including cold-steel dissection [21]. 4.4. Limitations This was a service evaluation to guide patient care at a local level and as such our study has some limitations. The small sample size makes our results susceptible to inflated effect size estimates but the possible association with increased pain at day 7 and reduced GP antibiotic prescribing necessitates a larger confirmatory study, perhaps using higher doses of morphine than ours. In any further study, the risk of respiratory depression in this patient group must be evenly weighed. For logistical reasons we could not monitor the administration of analgesia and fluid intake at the children’s homes. Due to parental attitudes about analgesia children often do not receive the recommend doses prescribed leading to poor fluid intake, and in turn dehydration, propagating a vicious cycle [3,22]. The effect of analgesia was not measured before and after administration and worst pain score on each postoperative day was not recorded. The use of heterogeneous questionnaires is a limitation but all scaled from 0 to 10 and allowed the varying age groups to be represented.
5. Conclusions In conclusion, we have found that morphine as rescue analgesia, at the doses used in this study, in addition to regular paracetamol and ibuprofen, does not alter the initial pain profile, worst pain
Please cite this article in press as: B. Oremule, et al., Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy, Int. J. Pediatr. Otorhinolaryngol. (2015), http://dx.doi.org/10.1016/j.ijporl.2015.09.040
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scores, or postoperative visits to healthcare services. The authors did find that there was a reduction in pharmacological intervention by GPs and that parents do require rescue analgesia for their children beyond a regular paracetamol and ibuprofen regime. Effective control of postoperative pain and patient education on expected pain levels is essential in order to reduce morbidity associated with tonsillectomy. 6. Summary There is no consensus for postoperative analgesia for breakthrough pain for children post-tonsillectomy/adenotonsillectomy. The majority of children undergoing tonsillectomy and adenotonisillectomy need additional postoperative analgesia other than regular paracetamol and ibuprofen. Take-home PRN morphine, at the doses used in this study, in addition to regular paracetamol and ibuprofen, did not alter the postoperative initial pain profile, worst pain scores or heath service contacts. This study found a reduction in GP pharmacological intervention with morphine use. Conflict of interest None declared.
Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/j.ijporl.2015.09. 040.
References [1] Commissioning guide: tonsillectomy 2013 ENT-UK, September 2013, https:// www.rcseng.ac.uk/healthcare-bodies/docs/published-guides/tonsillectomy (accessed 07.08.2015). [2] Royal College of Surgeons of England, National prospective tonsillectomy audit: final report of an audit carried out in England and Northern Ireland between July 2003 and September 2004, 2005, May. [3] R.F. Baugh, S.M. Archer, R.B. Mitchell, Clinical practice guideline: tonsillectomy in children, Otolaryngol. Head Neck Surg. 144 (2011) S1–S30.
[4] S. Shay, N.L. Shapiro, N. Bhattacharyya, Revisit rates and diagnoses following pediatric tonsillectomy in a large multistate population, Laryngoscope 125 (2015) 457–461, http://dx.doi.org/10.1002/lary.24783. [5] N.M. Power, R.F. Howard, A.M. Wade, L.S. Franck, Pain and behaviour changes in children following surgery, Arch. Dis. Child. 97 (2012) 879–884, http://dx.doi.org/ 10.1136/archdischild-2011-301378. [6] K.A. Sutters, C. Miaskowski, Inadequate pain management and associated morbidity in children at home after tonsillectomy, J. Pediatr. Nurs. 12 (1997) 178–185, http://dx.doi.org/10.1016/S0882-5963(97)80075-9. [7] R. Stewart, R. Bill, R. Ullah, P. McConaghy, S.J. Hall, Dexamethasone reduces pain after tonsillectomy in adults, Clin. Otolaryngol. Allied Sci. 27 (5) (2002) 321–326. [8] J.P. Willging, B.J. Wiatrak, Harmonic scalpel tonsillectomy in children: a randomized prospective, study, Otolaryngol. Head Neck Surg. 128 (3) (2003) 318–325. [9] L.E. Kelly, M. Rieder, J. van den Anker, B. Malkin, C. Ross, M.N. Neely, et al., More codeine fatalities after tonsillectomy in North American children, Pediatrics 129 (2012) e1343–e1347, http://dx.doi.org/10.1542/peds.2011-2538. [10] FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy, http://www.fda.gov/Drugs/DrugSafety/ucm339112.htm (Accessed on 6.02.14). [11] Medicine and Healthcare Products Regulatory Agency Drug Safety Update vol. 6, issue 12, July 2013: A1. [12] S.I. Merkel, T. Voepel-Lewis, J.R. Shayevitz, S. Malviya, The FLACC: a behavioral scale for scoring postoperative pain in young children, Pediatr. Nurs. 23 (1997) 293–297. [13] C.J. Cote´, J. Lerman, I. David Todres, A Practice of Anesthesia for Infants and Children, Elsevier Health Sciences, 2009p. 940 ISBN: 978-1-4160-3134-5. [14] P.E. Bijur, W. Silver, E.J. Gallagher, Reliability of the visual analog scale for measurement of acute pain, Acad. Emerg. Med. 8 (2001) 1153–1157, http:// dx.doi.org/10.1111/j.1553-2712.2001.tb01132.x. [15] J.A. Hannam, B.J. Anderson, M. Mahadevan, N.H.G. Holford, Postoperative analgesia using diclofenac and acetaminophen in children, Pediatr. Anesth. 24 (2014) 953–961, http://dx.doi.org/10.1111/pan.12422. [16] Steward D.L., J.A. Welge, C.M. Myer, Steroids for improving recovery following tonsillectomy in children (Cochrane review), in: The Cochrane Library, Issue 1, Wiley, London, 2003. [17] P. Boroumand, M.M. Zamani, M. Saeedi, O. Rouhbakhshfar, S.R. Hosseini Motlagh, F. Aarabi Moghaddam, Post tonsillectomy pain: can honey reduce the analgesic requirements? Anesth. Pain 3 (1) (2013) 198–202, http://dx.doi.org/10.5812/ aapm.9246. [18] Z. Fedorowicz, E.J. van Zuuren, M. Nasser, B. Carter, J.H. Al Langawi, Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy, Cochrane Database Syst. Rev. (9) (2013), http://dx.doi.org/10.1002/14651858. CD007806.pub4, Art. No.: CD007806.. [19] G.J. Tsao, A.H. Messner, J. Seybold, Z.N. Sayyid, A.G. Cheng, B. Golianu, Intraoperative acupuncture for posttonsillectomy pain: a randomized, double-blind, placebo-controlled trial, Laryngoscope (2015), http://dx.doi.org/10.1002/lary. 25252. [20] Kelly, Morphine or ibuprofen for post-tonsillectomy analgesia: a randomized, Trial Pediatr. 135 (2) (2015) 307–313. [21] M.J. Burton, C. Doree, Coblation versus other surgical techniques for tonsillectomy, Cochrane Database Syst. Rev. (3) (2007), http://dx.doi.org/10.1002/ 14651858.CD004619.pub2, Art. No.: CD004619. [22] R.Y.Z. Rony, M.A. Fortier, J.M.L. Chorney, D. Perret, Z.N. Kain, Parental postoperative pain management: attitudes, assessment, and management, Pediatrics 125 (2010) e1372.
Please cite this article in press as: B. Oremule, et al., Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy, Int. J. Pediatr. Otorhinolaryngol. (2015), http://dx.doi.org/10.1016/j.ijporl.2015.09.040
PEDOT-7787; No. of Pages 4 International Journal of Pediatric Otorhinolaryngology xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy B. Oremule *, M. Johnson, L. Sanderson, J. Lutz, J. Dodd, P. Hans Blackpool Teaching Hospitals NHS Trust, Blackpool, UK
A R T I C L E I N F O
A B S T R A C T
Article history: Received 24 May 2015 Received in revised form 24 September 2015 Accepted 30 September 2015 Available online xxx
Objectives: The withdrawal of codeine for use in children following tonsillectomy enforced a change in our practice of providing regular paracetamol and ibuprofen, with codeine for breakthrough pain relief. Our objectives were to; examine the effectiveness of paracetamol and ibuprofen; examine the effectiveness of the addition of rescue (PRN) morphine to regular paracetamol and ibuprofen. Methods: A 2 cycle prospective audit was conducted on our unit. Telephone consultations were conducted with parents of 74 children undergoing tonsillectomy and adenotonsillectomy. Cycle 1 (C1, without morphine) contained 24 consecutive patients and cycle 2 (C2, with morphine) contained 50 consecutive patients. Postoperative health service contact and outcome was recorded: worst pain scores on days 4 and 7 were obtained using validated pain assessment tools scoring 0–10. Cycle 2 results underwent subgroup analysis by method of surgery i.e. coblation (C2C) and cold steel dissection (C2D) groups. Results: More than half of parents felt simple analgesia was not effective enough in both cycles, this number was significantly higher in both 2nd cycle groups (C1 = 54%, C2C = 74%, p = 0.003, C2D = 84%, p = 0.0001). Mean worst pain reported at day 4 was similar for all groups, but the morphine groups reported higher pain at day 7 (C1 1.6, C2C 3.59, p = 0.017, C2D 3.90, p = 0.002). Antibiotic prescribing for children contacting a GP after surgery was significantly lower in the morphine groups (C1 24%, C2C 7%, p = 0.0014, C2D 5%, p = 0.0002). There was no difference in measured outcomes between the 2nd cycle groups. Conclusion: This service evaluation found that postoperative morphine on an as-required basis, in addition to regular paracetamol and ibuprofen, did not significantly alter initial pain profile, worst pain scores or rate of health service contact when compared to regular paracetamol and ibuprofen alone. The majority of children in this study felt additional analgesia required. Children in the morphine groups experienced significantly less pharmacological intervention when contacting the GP after surgery. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Paediatric Adenotonsillectomy Tonsillectomy Pain management Morphine
1. Introduction In 2012 there were 18,000 tonsillectomy operations performed on children in the National Health Service in England [1]. For an operation so widely performed mortality from tonsillectomy is low. A prospective audit of 33,921 tonsillectomies in England and Northern Ireland reported 1 death [2]. Despite the frequency of its performance, tonsillectomy is associated with significant morbidity. Postoperative complications include pain, bleeding, infection, postoperative nausea and vomiting (PONV) and sleep-disordered breathing [3]. A study in the United States including over 36,000
* Corresponding author. Tel.: +44 1253300000. E-mail address: [email protected] (B. Oremule).
children looked at 1st and 2nd revisit rates within 14 days amongst children undergoing tonsillectomy or adenotonsillectomy and found acute pain was the primary diagnosis in 18.4% and 11.2% respectively [4]. Acute pain causes fear, anxiety, distress and behavioural changes in children following surgery [5]. Pain following tonsillectomy is associated with decreased oral intake, dehydration, and latency in recovery after surgery [6]. Typically pain surges on postoperative day 4 or 5 before improving on day 6 [7,8]. Gauging analgesic requirements in this age group is problematic as younger age groups are unable to accurately communicate the amount of pain they are feeling. Routine practice in the United Kingdom sees the majority of children undergoing tonsillectomy looked after at home by parents or carers after the procedure and adds a layer of complexity in the management of the child’s postoperative pain.
http://dx.doi.org/10.1016/j.ijporl.2015.09.040 0165-5876/ß 2015 Elsevier Ireland Ltd. All rights reserved.
Please cite this article in press as: B. Oremule, et al., Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy, Int. J. Pediatr. Otorhinolaryngol. (2015), http://dx.doi.org/10.1016/j.ijporl.2015.09.040
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PEDOT-7787; No. of Pages 4 B. Oremule et al. / International Journal of Pediatric Otorhinolaryngology xxx (2015) xxx–xxx
2
1.1. Pain management quandary Kelly et al. [9] documented fatalities in children in North America due to postoperative codeine administration. Following these findings, the United States Federal Drug Agency placed a boxed warning and contraindication on codeine following tonsillectomy and adenotonsillectomy in children in 2013 and the Medicines and Healthcare Products Regulatory Agency (MHRA) closely followed suit [10,11]. A consensus on an alternative is yet to be agreed. At our hospital, we previously used a combination of paracetamol, ibuprofen and codeine for postoperative take-home analgesia. The prescription of codeine was stopped after the MHRA warning, and parents were advised to continue with regular paracetamol and ibuprofen. We wanted to assess the adequacy of this reduced analgesic regime, and provide an appropriate alternative breakthrough analgesic if it was found not to be adequate. 1.2. Aims Our aims were to: 1. Assess adequacy of postoperative paracetamol and ibuprofen alone. 2. Assess postoperative pain management following implementation of discharging patients with as-required (PRN) oral morphine. 3. Reduce health service contact attendance due to postoperative pain.
2. Method We undertook service evaluation by completing a prospective 2 cycle departmental audit on our paediatric tonsillectomy patients. Our Research and Development department deemed ethical approval not necessary for this study. In the first cycle, all children undergoing tonsillectomy and adenotonsillectomy were included (ages 1> to <16 years). Children <1 year or undergoing concomitant grommet insertion were excluded. Parents were asked to give their children regular ibuprofen three times daily, with meals, with regular paracetamol between ibuprofen doses. 24 consecutive patients from February 2014 to May 2014 were selected. Patients/carers were contacted on day 4 and day 7 post-operatively. They were asked whether additional analgesia was required (aside from paracetamol and ibuprofen), about worst pain scores and whether healthcare services were contacted, and if so what the outcome was. The inclusion and exclusion criteria were unchanged for the second cycle. Second cycle patients were provided with four day’s supply of oral morphine to be used for breakthrough pain relief. Morphine was dosed according to weight and age–at a reduced dose compared to doses published in the British National Formulary (BNF). This action was based on guidelines provided by Alder Hey Children’s Hospital (Appendix A). 50 consecutive patients from September 2014 to February 2015 were selected. Patients/carers were asked whether additional analgesia required (other than paracetamol and ibuprofen), about worst pain scores at day 4 and day 7, what day post-operatively did parents give morphine, whether healthcare services were contacted, and if so what the outcome was. All patients and their carers were given oral and written information designed at a local level at discharge, including the expected pain profile and safe administration of analgesia. The pain assessment tool used depended on the age and understanding of the child [12–14].
Analysis of the morphine group was subdivided into coblation and cold steel dissection groups to attempt to mitigate method of surgery as a confounding factor. Cold steel dissection tends to be carried out by junior surgical trainees at our hospital and this could possibly skew the results. Statistical analysis was carried out using SPSSTM Ver. 20.
3. Results In the 1st cycle the mean age of the children was 7.3 years (median 5.5, range 3–14 years, SD 3.86) (Table 1). Coblation tonsillectomy was used in all 24 children. 13/24 (54%) felt that additional analgesia was required. The mean worst pain score reported on day 4 was 4.98, 95% CI 3.35–6.6 (median 6, SD 3.86). This dropped to a mean score of 1.6 on day 7, 95% CI 0.79–2.41 (median 1, SD 1.92). The GP was contacted in the cases of 9 children (36%) children, 6 (24%) of whom were given antibiotics, 1 given difflam, another given PRN analgesia and the last had no outcome recorded. 1 child was re-admitted to ward on postoperative day 5 and given IV fluids. One of the patients given antibiotics was also given codeine by the GP. In the 2nd cycle the overall mean age of the children was 6.2 years (median 5, range 2–15 years, SD 2.9). Coblation tonsillectomy was used in 28 children, cold steel dissection in 19 and 3 operation methods were unrecorded. GP or walk-in centre contact was made for 9 (36%) children; 5 were given antibiotics and 4 were given advice. 1 child was re-admitted to the wards for intravenous fluid therapy on the second postoperative day. In the coblation group, the mean age of the children was 6.54 years (median 5, range 2–15 years, SD 3.43). 21/28 patients (75%) felt additional analgesia was required and all 21 used the morphine provided. Mean pain score reported after 4 days was 6.30, 95% CI 5.6–7 (range 2–10, SD 1.81). By day 7 this had dropped to 3.59, 95% CI 2.52–4.64 (range 0–10, SD 2.73). In those that used morphine, it was used on average at 3.33 days (SD 1.56) and for 2.52 days (range = 1–4, SD 1.17 days). 10/28 (36%) attended or contacted their GP, walk-in centre (WIC) or emergency department. Of these children, 7 were given advice, 2 antibiotics and 1 difflam. 3 children were re-admitted; 2 for intravenous fluids and 1 was returned to theatre due to a postoperative bleed. The dissection group contained 19 children; their mean age was 6.47 years (median 5, range 2–14, SD 3.67). 16/19 (84%) felt additional analgesia was required they all used the provided morphine; those that did not refrained from morphine use. On day 4 the mean pain score reported was 6.82, 95% CI 5.56–8.08 (range 1– 10, SD 2.62). By day 7 this had dropped to 3.90, 95% CI 2.87–4.93 (range 0–8, SD 2.13). 6/19 (32%) attended the GP, WIC or emergency department and 2 further children were re-admitted to the ward. Of the 6, 5 were given advice and 1 given antibiotics. In those children using morphine, the mean timing of first use was 3.56 days, 95% CI 2.84–4.29 (median, 4 range 1–6, SD 1.36) and it Table 1 Comparison of outcomes between Cycle 1 and Cycle 2 coblation groups.
Mean age (years) Needed additional analgesia Mean worst pain score day 4 Mean worst pain score day 7 Saw pain score reduce from day 4 to day 7 Attended GP or WIC Given antibiotic Re-admitted to ward
Cycle 1 (n = 24)
Cycle 2 Coblation (n = 28)
p-value
7.27 54% 4.98 1.60 79%
6.54 75% 6.30 3.59 82%
0.328 0.003 0.154 0.017 0.7215
36% 24% 4%
36% 7% 11%
1.0000 0.0014 0.1046
Please cite this article in press as: B. Oremule, et al., Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy, Int. J. Pediatr. Otorhinolaryngol. (2015), http://dx.doi.org/10.1016/j.ijporl.2015.09.040
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was used for an average of 2.94 days, 95% CI 1.92–3.96 (median 3, range 1–6, SD 1.91). 1 patient suffered from abdominal discomfort following liquid morphine, no other adverse effects were noted. Despite the fact codeine is listed as a contraindication in post-tonsillectomy and adenotonsillectomy in the British National Formulary for Children, one 11-year-old child was given codeine postoperatively by their GP in the first cycle. Data were not fully recorded for 3 patients and they were excluded from the analysis. 4. Discussion Regular simple analgesics i.e. paracetamol and non-steroidal anti-inflammatory drugs (NSAIDS) reduce postoperative pain and when used in combination reduce the amount needed of each drug [15]. The administration of a single intraoperative dose of steroid can reduce postoperative pain and has the added benefit of reducing PONV [16]. Other remedies such as honey and various mouthwashes and sprays have been tried with limited evidence of their efficacy [17,18]. More recently perioperative acupuncture has been studied specifically for its effect on postoperative pain in the paediatric population [19]. Despite regular use of simple analgesia breakthrough pain can still occur, requiring an opioid such as morphine or oxycodone. The rationale behind using morphine at our institution was that unlike codeine the surgical team could more reliably predict the pharmacokinetics of the drug, with the aim of providing adequate analgesia whilst preventing excessive respiratory depression. 4.1. Effect on postoperative pain More than half the children and carers in both groups felt that additional analgesia was required (Tables 1 and 2), indicating that the combination of regular paracetamol and ibuprofen, though effective, is not enough for the majority of children undergoing tonsillectomy. This feeling was significantly higher in the morphine group, both in the coblation and cold steel dissection arms. The authors postulate that the mere fact that morphine was given to the second group may have raised their expectations of postoperative pain and were therefore more likely to report it hence the higher mean worst pain scores seen in that group. Morphine was used on average on the 3rd postoperative day, slightly earlier than the expected surge in postoperative pain around the 4th postoperative day, but it did not appear to have a benefit in either delaying the surge of pain or dampening the pain felt on day 4, with similar pain scores reported for day 4 in all groups. There was no difference in the number that saw their pain reduce between postoperative days 4 and 7. Interestingly, children in the morphine group reported significantly higher pain scores on the 7th postoperative day, in both the coblation and dissection groups. We used significantly lower doses than recommended in the BNF (0.15 mg/kg); perhaps the doses Table 2 Comparison of outcomes between Cycle 1 and Cycle 2 dissection groups.
Mean age (years) Needed additional analgesia Mean worst pain score day 4 Mean worst pain score day 7 Saw pain score reduce from day 4 to day 7 Given antibiotic Attended GP or WIC Re-admitted to ward
Cycle 1 (n = 24)
Cycle 2 (dissection) (n = 19)
p-value
7.27 54% 4.98 1.60 79%
6.47 84% 6.82 3.90 84%
0.383 0.0001 0.891 0.002 0.4667
24% 36% 4%
5% 32% 11%
0.0002 0.6545 0.1046
3
Table 3 Comparison of outcomes between Cycle 2 coblation and dissection groups. Cycle 2 (coblation) Cycle 2 (dissection) p-value (n = 28) (n = 19) Mean age (years) Needed additional analgesia Mean worst pain score day 4 Mean worst pain score day 7 Saw pain score reduce from day 4 to day 7 Attended GP or WIC Given antibiotic Re-admitted to ward
6.54 75% 6.30 3.59 82%
6.47 84% 6.82 3.90 84%
0.9471 0.1606 0.4245 0.6794 0.8409
36% 7% 11%
32% 5% 11%
0.6545 0.7673 1.0000
were too low to combat the expectation levels of the parents and children. The authors were wary of the dangerous possibility of respiratory depression in this group of patients. We were mindful that Kelly et al. [20] showed the risk of respiratory depression is real, even at recommended doses. 4.2. Other effects Morphine did not appear to confer any benefit in the reduction of overall postoperative GP, WIC, emergency department attendance or re-admission. However, of note, there was a highly statistically significant drop in the number of patients prescribed postoperative antibiotics. One hypothesis to explain this occurrence is that in the second cycle, where patients already had morphine, GPs felt more comfortable telling them to use the morphine for the pain and not resort to antibiotics as a means of helping with pain. 4.3. Coblation versus cold-steel dissection There were no significant differences in measured outcomes between the coblation and dissection groups (Table 3). Our results concur with a recent Cochrane review that did not find sufficient evidence to find coblation better or worse for postoperative pain or speed and safety of recovery than other surgical techniques including cold-steel dissection [21]. 4.4. Limitations This was a service evaluation to guide patient care at a local level and as such our study has some limitations. The small sample size makes our results susceptible to inflated effect size estimates but the possible association with increased pain at day 7 and reduced GP antibiotic prescribing necessitates a larger confirmatory study, perhaps using higher doses of morphine than ours. In any further study, the risk of respiratory depression in this patient group must be evenly weighed. For logistical reasons we could not monitor the administration of analgesia and fluid intake at the children’s homes. Due to parental attitudes about analgesia children often do not receive the recommend doses prescribed leading to poor fluid intake, and in turn dehydration, propagating a vicious cycle [3,22]. The effect of analgesia was not measured before and after administration and worst pain score on each postoperative day was not recorded. The use of heterogeneous questionnaires is a limitation but all scaled from 0 to 10 and allowed the varying age groups to be represented.
5. Conclusions In conclusion, we have found that morphine as rescue analgesia, at the doses used in this study, in addition to regular paracetamol and ibuprofen, does not alter the initial pain profile, worst pain
Please cite this article in press as: B. Oremule, et al., Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy, Int. J. Pediatr. Otorhinolaryngol. (2015), http://dx.doi.org/10.1016/j.ijporl.2015.09.040
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scores, or postoperative visits to healthcare services. The authors did find that there was a reduction in pharmacological intervention by GPs and that parents do require rescue analgesia for their children beyond a regular paracetamol and ibuprofen regime. Effective control of postoperative pain and patient education on expected pain levels is essential in order to reduce morbidity associated with tonsillectomy. 6. Summary There is no consensus for postoperative analgesia for breakthrough pain for children post-tonsillectomy/adenotonsillectomy. The majority of children undergoing tonsillectomy and adenotonisillectomy need additional postoperative analgesia other than regular paracetamol and ibuprofen. Take-home PRN morphine, at the doses used in this study, in addition to regular paracetamol and ibuprofen, did not alter the postoperative initial pain profile, worst pain scores or heath service contacts. This study found a reduction in GP pharmacological intervention with morphine use. Conflict of interest None declared.
Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/j.ijporl.2015.09. 040.
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Please cite this article in press as: B. Oremule, et al., Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy, Int. J. Pediatr. Otorhinolaryngol. (2015), http://dx.doi.org/10.1016/j.ijporl.2015.09.040