Postoperative Oral Dexamethasone and Pediatric Tonsillectomy Morbidity: A Randomized Clinical Trial

Abstract

Importance Tonsillectomy is among the most painful otolaryngologic procedures. It is unclear whether a postoperative course of oral steroids reduces pediatric tonsillectomy pain and morbidity. Objective To determine whether a postoperative course of oral dexamethasone reduces postadenotonsillectomy pain in children. Design, Setting, and Participants This was a parallel-design quadruple-blinded randomized clinical trial conducted at a single tertiary academic center that enrolled pediatric patients (3-17 years of age) undergoing adenotonsillectomy from August 2021 to May 2023, with 14 days of follow-up for pain and 5 to 9 weeks for adverse events. Data were analyzed from October 2023 to May 2026. Intervention Oral dexamethasone (0.5 mg/kg; maximum dose, 20 mg) or placebo on postoperative days 2, 4, and 6. Main Outcome and Measure Mean (SD) pain score before medication administered during days 2 to 8 postoperatively. Results Of 763 children screened, 209 participants (median [IQR] age, 7.1 [5.8] years; 99 females [47.4%] and 110 males [52.6%]) were included (104 to the steroid arm and 105 to placebo) in analyses of adverse events and health care utilization. Of these, 131 (61 steroid arm and 70 placebo) completed pain diaries and were included in primary outcome (pain) analysis. Mean (SD) pain before acetaminophen or ibuprofen on days 2 to 8 was 0.72 (95% CI, 0-1.44) points lower in the dexamethasone group (4.12 [2.00]) than placebo (4.84 [2.15]), but wide 95% CIs and differences in pain prior to taking the study medication prevented making definitive conclusions. The dexamethasone group had less pre- and postanalgesic pain on postoperative days 12 and 13 (mean difference, 0.96-2.37 points) and a considerable decrease in odds of receiving an opioid prescription (odds ratio [OR], 0.23; 95% CI, 0.06-0.84) or having an emergency department visit for pain (OR, 0.12; 95% CI, 0.003-0.91). However, the precision of these estimates limits interpretability. Differences in readmissions, nursing telephone calls, posttonsillectomy hemorrhage, and return to normal diet between groups were small and clinically meaningless. Conclusions and Relevance In this randomized clinical trial, postoperative oral dexamethasone was associated with a modest reduction in pain after pediatric adenotonsillectomy, a considerable reduction in opioid prescriptions, and no increase in complications, supporting its use as an analgesic adjunct. Trial Registration ClinicalTrials.gov Identifier: NCT04879823