Purpose: To examine the effects of preoperative gabapentin administration on postoperative pain in pediatric patients undergoing tonsillectomy/adenoidectomy (T/A) in a single ambulatory surgery location within a pediatric healthcare organization.
Design: This randomized, controlled pilot study enrolled patients age 3-18 years with American Society of Anesthesiologists (ASA) scores of I-II undergoing T/A.
Methods: Both gabapentin and placebo groups were given study medication preoperatively and received standard opiate regimens intraoperatively and postoperative pain instructions. Outcome measurements included: time to first analgesic medication in the postanesthesia care unit (PACU), mean acetaminophen, ibuprofen, and opiate doses in mg/kg. Additionally, we examined pain scores, medication use, and side effects reported by daily pain diaries completed by patients/families for 3 days postoperatively.
Findings: Forty-nine patients were included in final analysis (gabapentin n = 26, placebo n = 23). Demographic and clinical characteristics of both groups were similar; the majority (46 of 49) were under the age of 13. Both groups received opiates in PACU. Some patients in both groups received hydrocodone/acetaminophen postoperatively. There were no reported differences in side effects between groups. Gabapentin group reported less use of opiates, acetaminophen, and ibuprofen post-discharge. We identified small effect sizes for opiates and acetaminophen, and medium effect size for ibuprofen (80.1% gabapentin versus 100% placebo, RR 0.81 [95% CI 0.67-0.97]). Median pain scores were 4 on a scale of 10 for both groups for all 3 days of follow-up. Overall median satisfaction score was 9, with a mean difference of 0.35 (95% CI -0.78 - 1.37). Analysis of variance revealed no difference in pain scores or satisfaction per pain diaries between the groups in general and no difference in score trajectory.
Conclusions: We were able to establish a rigorous process and feasibility to launch a larger, multi-center trial to examine this important issue. There remain few evidence-based options for acute pain relief in pediatric surgical populations besides opiates. Identifying opiate alternatives that are effective, cost efficient and safe are needed for pediatric tonsillectomy patients.
Trial registration: ClinicalTrials.gov NCT03417479.
Keywords: Gabapentin; opiates; pediatrics; postoperative pain; tonsillectomy/adenoidectomy.
Copyright © 2021 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.