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Ketamine Gargle for Pain After Pediatric Tonsillectomy
Sponsor: Hospital Universitario de Caracas
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.
Official title: Preemptive Topical Ketamine for Post-Tonsillectomy Analgesia: A Randomized, Double-Blind, Placebo-Controlled Trial in Children
Key Details
Gender
All
Age Range
4 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2024-01-10
Completion Date
2025-01-14
Last Updated
2026-05-05
Healthy Volunteers
Yes
Interventions
Ketamine Hydrochloride in saline
Ketamine gargle at a dose of 40mg diluted in 30 mL of normal saline, administered 5 minutes before induction of anesthesia. Patients were instructed to gargle the solution for 30 seconds and then expectorate.
Normal Saline (0.9% NaCl)
Placebo gargle consisting of 30 mL of normal saline, administered 5 minutes before induction of anesthesia. Patients were instructed to gargle the solution for 30 seconds and then expectorate.
Locations (1)
VERAZA
Caracas, Miranda, Venezuela