Dexamethasone and risk of nausea and vomiting and postoperative bleeding after tonsillectomy in children: a randomized trial

JAMA. 2008 Dec 10;300(22):2621-30. doi: 10.1001/jama.2008.794.

Abstract

Context: Dexamethasone is widely used to prevent postoperative nausea and vomiting (PONV) in pediatric tonsillectomy.

Objective: To assess whether dexamethasone dose-dependently reduces the risk of PONV at 24 hours after tonsillectomy.

Design, setting, and patients: Randomized placebo-controlled trial conducted among 215 children undergoing elective tonsillectomy at a major public teaching hospital in Switzerland from February 2005 to December 2007.

Interventions: Children were randomly assigned to receive dexamethasone (0.05, 0.15, or 0.5 mg/kg) or placebo intravenously after induction of anesthesia. Acetaminophen-codeine and ibuprofen were given as postoperative analgesia. Follow-up continued until the 10th postoperative day.

Main outcome measures: The primary end point was prevention of PONV at 24 hours; secondary end points were decrease in the need for ibuprofen at 24 hours and evaluation of adverse effects.

Results: At 24 hours, 24 of 54 participants who received placebo (44%; 95% confidence interval [CI], 31%-59%) had experienced PONV compared with 20 of 53 (38%; 95% CI, 25%-52%), 13 of 54 (24%; 95% CI, 13%-38%), and 6 of 52 (12%; 95% CI, 4%-23%) who received dexamethasone at 0.05, 0.15, and 0.5 mg/kg, respectively (P<.001 for linear trend). Children who received dexamethasone received significantly less ibuprofen. There were 26 postoperative bleeding episodes in 22 children. Two of 53 (4%; 95% CI, 0.5%-13%) children who received placebo had bleeding compared with 6 of 53 (11%; 95% CI, 4%-23%), 2 of 51 (4%; 95% CI, 0.5%-13%), and 12 of 50 (24%; 95% CI, 13%-38%) who received dexamethasone at 0.05, 0.15, and 0.5 mg/kg, respectively (P = .003). Dexamethasone, 0.5 mg/kg, was associated with the highest bleeding risk (adjusted relative risk, 6.80; 95% CI, 1.77-16.5). Eight children had to undergo emergency reoperation because of bleeding, all of whom had received dexamethasone. The trial was stopped early for safety reasons.

Conclusion: In this study of children undergoing tonsillectomy, dexamethasone decreased the risk of PONV dose dependently but was associated with an increased risk of postoperative bleeding.

Trial registration: clinicaltrials.gov Identifier: NCT00403806.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Analgesics, Non-Narcotic / therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Antiemetics / administration & dosage
  • Antiemetics / therapeutic use*
  • Child
  • Child, Preschool
  • Dexamethasone / administration & dosage
  • Dexamethasone / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Ibuprofen / therapeutic use
  • Male
  • Pain, Postoperative / drug therapy
  • Postoperative Hemorrhage / epidemiology*
  • Postoperative Nausea and Vomiting / prevention & control*
  • Risk
  • Tonsillectomy*

Substances

  • Analgesics, Non-Narcotic
  • Anti-Inflammatory Agents, Non-Steroidal
  • Antiemetics
  • Dexamethasone
  • Ibuprofen

Associated data

  • ClinicalTrials.gov/NCT00403806