drugset / Trial / NCT07558044

Ketamine Gargle for Pain After Pediatric Tonsillectomy

NCT07558044 ↗

Phase 4 Completed 420 enrolled Hospital Universitario de Caracas
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Post-tonsillectomy pain in children is a common and clinically significant problem that may lead to poor oral intake, dehydration, and delayed recovery. This study evaluates whether a simple preoperative intervention-gargling with ketamine-can reduce postoperative pain and improve recovery after pediatric adenotonsillectomy. In this randomized, double-blind, placebo-controlled trial, 420 children aged 4 to 12 years undergoing elective adenotonsillectomy were assigned to receive either a ketamine gargle (40 mg in saline) or a saline placebo prior to anesthesia induction. Pain intensity was measured using the Visual Analog Scale at multiple time points within the first 24 hours after surgery. Secondary outcomes included postoperative bleeding requiring reintervention, analgesic consumption, and adverse events. The study aims to determine whether topical ketamine provides effective and safe analgesia as part of an opioid-sparing strategy in pediatric airway surgery.

Timeline

Start
2024-01-10
Primary completion
2025-01-07
Completion
2025-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 40 mg Other

Indications

No indication recorded.