drugset / Trial / NCT02727491

Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

NCT02727491

Phase 4 Completed 85 enrolled Dr. Rachel Rooney
RandomizedParallel-groupQuadruple-blindTreatment

Summary

With Institutional ethics board and Health Canada approval, pediatric patients (ages 3-12) undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively and again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and volume) at the same time points. The primary outcome is an integrated assessment of perioperative pain scores and opioid use for 24 hours postoperatively. Secondary outcomes include nausea, vomiting, respiratory depression, and bleeding for 24 hours postoperatively. Our hypothesis is that dextromethorphan will decrease the incidence/severity of post-tonsillectomy pain. The improved pain control will be apparent through reduced opioid consumption and integrated pain scores. This will result in a reduced incidence of opioid-related side effects and adverse events.

Timeline

Start
2012-03
Primary completion
2014-09
Completion
2014-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextromethorphan Unknown 1 mg/kg Oral

Indications