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Abstracts (776) Use of opioid analgesia in a trauma/neurosurgical intensive care unit J Innis, J Topolovec-Vranic, S Canzian, M Pollman, A White McFarlan; St. Michael’s Hospital, Toronto, ON, Canada In the intensive care setting, patients often have pain that is unrelieved or inadequately managed. Pain management is particularly challenging in patients who are unable to self-report their pain levels. Poorly managed pain is associated with a number of adverse outcomes. This descriptive study compared pain management practices between neurosurgical and trauma patients in a Trauma/Neurosurgical Intensive Care Unit (TNICU) at an urban teaching hospital. It was hypothesized that traumatically injured patients would receive more opioid analgesia than the neurosurgical patients in the same unit. Medical chart audits (n⫽27) were completed to measure the amount of opioid each patient received. The amount of morphine equivalent units for trauma patients (n⫽13) and neurosurgical patients (n⫽14) was then compared. As hypothesized, the trauma patients received more opioid analgesia than the neurosurgical patients. The mean amounts of morphine equivalent units per day were found to be 21.1 for the trauma patients and 13.8 for the neurosurgical patients. While this result was not statistically significant, it suggests current trends in pain management practice in this TNICU. Although the trauma patients were found to receive more analgesia, most of these patients received less than 10 morphine units per day even though they had multiple injuries. Patients often receive less analgesia when they are cognitively impaired and/or unable to communicate. Neurosurgical patients may have sub-optimal pain management due to the fear that opioid analgesia will impair neurological assessment. This descriptive study highlights the need for pain assessment tools for the non-verbal critically ill patient, as well as the need for increased pain management.
D17 - Perioperative Pain: Opioids (777/Paper 318) LNS5662 (Flavonol-PgP Modulator) ameliorates CNS effects of oxycodone in an acute pain model S Gordon, D Coletti, S Bergman, N Shimizu, J Caccamese, G Laska, V Lee, W Schmidt, W Robbins; University of Maryland, Baltimore, MD Opioids frequently produce adverse CNS side effects in ambulatory settings, providing a rationale for improving opioid analgesia by minimizing adverse effects. LNS5662 is a flavonol which is thought to activate PgP efflux of pump ligands at the blood brain barrier. In this pilot study, we tested the hypothesis that LNS5662 improves the tolerability and safety of oxycodone without impairing analgesia. Healthy subjects (N⫽65) undergoing third molar removal were randomly allocated to receive 500 mg oral LNS5662 or matching placebo at 1 hr prior to surgery. All subjects received 10 mg oral oxycodone immediately prior to surgery. As expected, pupil size decreased with increasing oxycodone plasma concentration. Oxycodone concentrations did not differ between groups prior to surgery, at 1 hr, or at 4 hr. Total Nausea and Vomiting Score (TNVS) was calculated for the time from dosing through 24 hr. More subjects in the LNS5662 group (67%) than in the placebo group (56%) experienced “no” nausea or vomiting. Median TNVS was 0.39 (LNS5662) and 0.56 (placebo). No subjects in the LNS5662 group experienced the most severe level of nausea or vomiting vs 3 in the placebo group. Fewer subjects in the LNS5662 group (33.3%) than the placebo group (43.8%) requested anti-emetic, and the placebo group tended to request anti-emetic sooner (280 vs 306 min). Importantly, the LNS5662 treated group had lower mean pain intensity than the placebo group. All subjects except one requested additional analgesic doses; there was no difference in median time to request for a second analgesic (120 and 131 min, respectively). LNS5662 given 1 hr prior to oxycodone may ameliorate the severity of nausea and vomiting while not interfering with analgesic efficacy. A study with additional LNS5662 doses and a larger sample size is needed to confirm these results.
S45 (778) Analgesic efficacy of DepoDur® alone, or in combination with bupivacaine, for low abdominal surgery: A randomized, placebo-controlled trial D Gambling, T Hughes, J Campbell, G Manvelian SkyePharma Inc., San Diego, CA DepoDur® (liposome-encapsulated morphine) is a single-dose epidural analgesic providing postoperative pain relief for up to 48 hours. The efficacy of DepoDur combined with local anesthetics for postoperative analgesia is unknown. This study assessed the efficacy of DepoDur (15 mg) alone and following epidural bupivacaine. DepoDur or placebo was administered 15, 30, or 60 minutes after a preoperative dose of 20ml 0.25% bupivacaine. Various pain assessments were made postoperatively and adverse events (AEs) were recorded. For all efficacy endpoints, DepoDur with bupivacaine was superior to bupivacaine alone. Combined treatment was not different from DepoDur alone. Mean ⫾ SD cumulative fentanyl use ranged from 552⫾748 g to 985⫾1333 g in the DepoDur groups vs 3817⫾3844 g with bupivacaine alone (P⬍0.05). Mean ⫾SD 48-hour area under the pain intensity–time curves with activity were lower (P⬍0.05) in DepoDur-treated patients compared to bupivacaine alone. More patients and surgeons rated pain control as good or very good in the DepoDur groups compared with bupivacaine alone (P⬍0.05). AEs were lowest with bupivacaine alone and similar across DepoDur groups. Nausea and vomiting were more frequent after DepoDur with bupivacaine (75% and 37%) compared to DepoDur (59% and 19%) or bupivacaine alone (52% and 13%). Respiratory depression related to DepoDur occurred in 1 patient receiving DepoDur alone versus 6 patients receiving DepoDur with bupivacaine. In summary, a single perioperative dose of DepoDur appears equally effective when administered alone or with bupivacaine but the combination may increase some AEs such as nausea and vomiting. Supported by Endo Pharmaceuticals Inc. and SkyePharma Inc.
(779) Effectiveness of a scheduled oral analgesic dosing regimen for the management of postoperative pain in school-age children following tonsillectomy K Sutters, C Miaskowski, S Paul, M Savedra, S Waite, D Holdridge-Zeuner, K Mahoney, B Lanier; Children’s Hospital Central California, Madera, CA The purpose of this RCT, with children undergoing tonsillectomy, was to determine the effectiveness of scheduled analgesic administration, with or without nurse coaching, over time, compared to standard care with PRN dosing. Children (ages 6 to 15 years; N⫽113), were randomized to one of three treatment groups to receive acetaminophen with hydrocodone (167mg/2.5mg/5ml) for 3 days after surgery; Group A (N⫽39) – every 4 hours PRN, with standard postoperative instructions; Group B (N⫽34) – every 4 hours ATC, with standard postoperative instructions, without nurse coaching; and, Group C (N⫽40) – every 4 hours ATC, with standard postoperative instructions with coaching. Pain intensity was recorded at discharge, then twice a day, for the first 3 days at home, using a 0-10 scale. Parents completed a medication log. No differences were found in analgesic administration or pain intensity scores between the 2 ATC groups; therefore, they were combined for comparison to the PRN group. Pain intensity scores decreased over time for children in both the PRN and ATC groups at rest (p⬍0.0001) and with swallowing (p⬍0.0001). Children in the PRN group had higher pain intensity scores compared to children in the ATC group, both at rest (F(1,107)⫽5.849, p⫽0.017) and with swallowing (F(1,107)⫽4.36, p⫽0.017). Pain intensity scores for both groups were higher in the morning compared to the evening (F(1,110)⫽35.984, p⬍0.0001). Children in the ATC group received significantly greater amounts of analgesic than children in the PRN group (F(2,101)⫽28.384, p⬍0.0001). Study results suggest that scheduled dosing of acetaminophen with hydrocodone is more effective than PRN dosing at reducing pain intensity in children following tonsillectomy. Pain intensity is higher in the morning compared to the evening. Prescribed ATC dosing results in greater analgesic consumption compared to PRN dosing, and nurse coaching does not impact parent’s adherence to the ATC dosing schedule. Supported by a grant from NINRNR04826.
D17 - Perioperative Pain: Opioids (777/Paper 318) LNS5662 (Flavonol-PgP Modulator) ameliorates CNS effects of oxycodone in an acute pain model S Gordon, D Coletti, S Bergman, N Shimizu, J Caccamese, G Laska, V Lee, W Schmidt, W Robbins; University of Maryland, Baltimore, MD Opioids frequently produce adverse CNS side effects in ambulatory settings, providing a rationale for improving opioid analgesia by minimizing adverse effects. LNS5662 is a flavonol which is thought to activate PgP efflux of pump ligands at the blood brain barrier. In this pilot study, we tested the hypothesis that LNS5662 improves the tolerability and safety of oxycodone without impairing analgesia. Healthy subjects (N⫽65) undergoing third molar removal were randomly allocated to receive 500 mg oral LNS5662 or matching placebo at 1 hr prior to surgery. All subjects received 10 mg oral oxycodone immediately prior to surgery. As expected, pupil size decreased with increasing oxycodone plasma concentration. Oxycodone concentrations did not differ between groups prior to surgery, at 1 hr, or at 4 hr. Total Nausea and Vomiting Score (TNVS) was calculated for the time from dosing through 24 hr. More subjects in the LNS5662 group (67%) than in the placebo group (56%) experienced “no” nausea or vomiting. Median TNVS was 0.39 (LNS5662) and 0.56 (placebo). No subjects in the LNS5662 group experienced the most severe level of nausea or vomiting vs 3 in the placebo group. Fewer subjects in the LNS5662 group (33.3%) than the placebo group (43.8%) requested anti-emetic, and the placebo group tended to request anti-emetic sooner (280 vs 306 min). Importantly, the LNS5662 treated group had lower mean pain intensity than the placebo group. All subjects except one requested additional analgesic doses; there was no difference in median time to request for a second analgesic (120 and 131 min, respectively). LNS5662 given 1 hr prior to oxycodone may ameliorate the severity of nausea and vomiting while not interfering with analgesic efficacy. A study with additional LNS5662 doses and a larger sample size is needed to confirm these results.
S45 (778) Analgesic efficacy of DepoDur® alone, or in combination with bupivacaine, for low abdominal surgery: A randomized, placebo-controlled trial D Gambling, T Hughes, J Campbell, G Manvelian SkyePharma Inc., San Diego, CA DepoDur® (liposome-encapsulated morphine) is a single-dose epidural analgesic providing postoperative pain relief for up to 48 hours. The efficacy of DepoDur combined with local anesthetics for postoperative analgesia is unknown. This study assessed the efficacy of DepoDur (15 mg) alone and following epidural bupivacaine. DepoDur or placebo was administered 15, 30, or 60 minutes after a preoperative dose of 20ml 0.25% bupivacaine. Various pain assessments were made postoperatively and adverse events (AEs) were recorded. For all efficacy endpoints, DepoDur with bupivacaine was superior to bupivacaine alone. Combined treatment was not different from DepoDur alone. Mean ⫾ SD cumulative fentanyl use ranged from 552⫾748 g to 985⫾1333 g in the DepoDur groups vs 3817⫾3844 g with bupivacaine alone (P⬍0.05). Mean ⫾SD 48-hour area under the pain intensity–time curves with activity were lower (P⬍0.05) in DepoDur-treated patients compared to bupivacaine alone. More patients and surgeons rated pain control as good or very good in the DepoDur groups compared with bupivacaine alone (P⬍0.05). AEs were lowest with bupivacaine alone and similar across DepoDur groups. Nausea and vomiting were more frequent after DepoDur with bupivacaine (75% and 37%) compared to DepoDur (59% and 19%) or bupivacaine alone (52% and 13%). Respiratory depression related to DepoDur occurred in 1 patient receiving DepoDur alone versus 6 patients receiving DepoDur with bupivacaine. In summary, a single perioperative dose of DepoDur appears equally effective when administered alone or with bupivacaine but the combination may increase some AEs such as nausea and vomiting. Supported by Endo Pharmaceuticals Inc. and SkyePharma Inc.
(779) Effectiveness of a scheduled oral analgesic dosing regimen for the management of postoperative pain in school-age children following tonsillectomy K Sutters, C Miaskowski, S Paul, M Savedra, S Waite, D Holdridge-Zeuner, K Mahoney, B Lanier; Children’s Hospital Central California, Madera, CA The purpose of this RCT, with children undergoing tonsillectomy, was to determine the effectiveness of scheduled analgesic administration, with or without nurse coaching, over time, compared to standard care with PRN dosing. Children (ages 6 to 15 years; N⫽113), were randomized to one of three treatment groups to receive acetaminophen with hydrocodone (167mg/2.5mg/5ml) for 3 days after surgery; Group A (N⫽39) – every 4 hours PRN, with standard postoperative instructions; Group B (N⫽34) – every 4 hours ATC, with standard postoperative instructions, without nurse coaching; and, Group C (N⫽40) – every 4 hours ATC, with standard postoperative instructions with coaching. Pain intensity was recorded at discharge, then twice a day, for the first 3 days at home, using a 0-10 scale. Parents completed a medication log. No differences were found in analgesic administration or pain intensity scores between the 2 ATC groups; therefore, they were combined for comparison to the PRN group. Pain intensity scores decreased over time for children in both the PRN and ATC groups at rest (p⬍0.0001) and with swallowing (p⬍0.0001). Children in the PRN group had higher pain intensity scores compared to children in the ATC group, both at rest (F(1,107)⫽5.849, p⫽0.017) and with swallowing (F(1,107)⫽4.36, p⫽0.017). Pain intensity scores for both groups were higher in the morning compared to the evening (F(1,110)⫽35.984, p⬍0.0001). Children in the ATC group received significantly greater amounts of analgesic than children in the PRN group (F(2,101)⫽28.384, p⬍0.0001). Study results suggest that scheduled dosing of acetaminophen with hydrocodone is more effective than PRN dosing at reducing pain intensity in children following tonsillectomy. Pain intensity is higher in the morning compared to the evening. Prescribed ATC dosing results in greater analgesic consumption compared to PRN dosing, and nurse coaching does not impact parent’s adherence to the ATC dosing schedule. Supported by a grant from NINRNR04826.