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Ketamine Gargle for Pain After Pediatric Tonsillectomy

NCT07558044 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Postoperative Pain
  • Tonsillectomy
  • Adenotonsillectomy

Interventions

DRUG

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.

OTHER

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.

Sponsors & Collaborators

  • Hospital Universitario de Caracas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Venezuela

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07558044 on ClinicalTrials.gov