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Randomized Controlled Trial
. 2025 Aug;173(2):392-401.
doi: 10.1002/ohn.1280. Epub 2025 May 21.

Opioid Analgesia Following Pediatric Adenotonsillectomy: A Randomized Clinical Trial

Rachel L Whelan  1   2 , Jennifer L McCoy  1 , Leonid Mirson  2 , Raymond C Maguire  1   2 , Noel Jabbour  1   2 , Jeffrey P Simons  1   2 , Joseph E Dohar  1   2 , Dennis J Kitsko  1   2 , Amanda L Stapleton  1   2 , Allison B J Tobey  1   2 , Cuneyt M Alper  1   2 , Amber D Shaffer  1 , Zachary R Bennett  1   2 , David H Chi  1   2
Affiliations
Randomized Controlled Trial

Opioid Analgesia Following Pediatric Adenotonsillectomy: A Randomized Clinical Trial

Rachel L Whelan et al. Otolaryngol Head Neck Surg. 2025 Aug.

Abstract

Objective: To compare the safety and efficacy of nonopioid versus opioid pain management following adenotonsillectomy (AT) among pediatric patients.

Study design: An open-label randomized controlled trial.

Setting: Tertiary care children's hospital.

Methods: Patients aged 3 to 17 years undergoing AT were eligible. Participants were randomly assigned to receive either acetaminophen and ibuprofen (nonopioid group) or acetaminophen, ibuprofen, and oxycodone (opioid group). Pain scores and prevalence of emergency department (ED) visits, hospital readmission, and posttonsillectomy hemorrhage (PTH) were compared between groups.

Results: From January 2019 to March 2020, 267 patients were enrolled and randomly assigned; 144 completed a postoperative pain diary. Of the 144, 69 (48%) patients received an opioid prescription, and 75 (52%) did not. Mean pain scores before (opioid: 5.78, 95% CI: 5.29-6.27 vs nonopioid: 5.66, 95% CI: 5.20-6.12) and after (opioid: 2.33, 95% CI: 1.89-2.78 vs nonopioid: 2.24, 95% CI: 1.82-2.66) analgesics were not significantly different between opioid and nonopioid groups. Although 7/75 (9%) from the nonopioid group crossed over and requested opioids, only 43/69 (62%) randomly assigned to receive opioid prescription consumed opioids. The rate of opioid consumption increased with increasing age: 18/71 (25%) patients aged 3 to 7 years, 22/57 (39%) 8 to 12 years, and 10/16 (63%) 13 to 17 years, P = .015. Differences in ED visits, hospital readmissions, and PTH between opioid and nonopioid groups were not significant.

Conclusion: Many children do not require opioid analgesics following AT, particularly children less than 8 years of age. Postoperative pain scores and outcomes were similar in opioid versus nonopioid groups. Opioid prescriptions should be limited or avoided altogether after pediatric AT.

Trial registration: Title: Nonopioids for analgesia after adenotonsillectomy in children; ID: NCT03618823, Clinicaltrials.gov.

Keywords: opioid prescription; pediatric opioid; postoperative opioid; postoperative pain; tonsillectomy pain.

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Conflict of interest statement

There are no conflicts of interest to disclose for any author.

Figures

Figure 1
Figure 1
Wong‐Baker FACES Pain Rating Scale and a portion of the self‐reported pain diary.
Figure 2
Figure 2
Study inclusion flow diagram (CONSORT).
Figure 3
Figure 3
(A) Average daily pain scores between intention‐to‐treat opioid and nonopioid groups on a scale of 0 to 10, mean (standard error of the mean). (B) Subgroup analysis of average daily pain scores between patients who did not cross over between groups on a scale of 0 to 10, mean (standard error of the mean).
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