Clinical Trial

Ketamine Gargle for Pain After Pediatric Tonsillectomy

Study acronym: KET-TONSIL
Completed Phase 4
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-23.
Trial Details
NCT Number NCT07558044
Lead Sponsor Hospital Universitario de Caracas
Conditions Postoperative Pain, Tonsillectomy, Adenotonsillectomy
Enrollment 420 participants
Start Date 2024-01-10
Primary Completion 2025-01-07 (estimated)
Study Completion 2025-01-14 (estimated)
Updated on ClinicalTrials.gov 2026-05-05