drugset / Trial / NCT04541147

Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

NCT04541147

Phase 4 Terminated 24 enrolled Duke University
RandomizedParallel-groupOpen-labelSupportive care

Summary

The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy. Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment. Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.

Timeline

Start
2021-04-14
Primary completion
2023-12-26
Completion
2023-12-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.5 mg/kg Oral
Background Acetaminophen Small molecule 10 mg/kg
Background Acetaminophen Small molecule 15 mg/kg
Background Ibuprofen Small molecule 5 mg/kg
Background Ibuprofen Small molecule 10 mg/kg
Background Oxycodone Other / unclassified 0.05 mg/kg
Background Oxycodone Other / unclassified 0.1 mg/kg

Indications