Ketamine Gargle for Pain After Pediatric Tonsillectomy

NCT07558044 | Completed Phase 4

• 1 other identifier: KET-AT-2024-01
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ketamine gargle; pediatric anesthesia; postoperative analgesia; NMDA receptor antagonist; opioid-sparing analgesia; airway surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Pain intensity measured using the Visual Analog Scale (VAS; 0-10) at predefined postoperative time points.

  0, 4, 8, 12, and 24 hours postoperatively

Secondary Outcomes (3)

• Postoperative hemorrhage requiring surgical reintervention

  Within 24 hours postoperatively

• Rescue analgesic consumption

  24 hours postoperatively

• Adverse events

  24 hours postoperatively

Study Arms (2)

KETAMINE GROUP

EXPERIMENTAL

Preoperative gargle with 40 mg ketamine diluted in 30 mL saline, administered 5 minutes before induction of anesthesia.

Drug: Ketamine Hydrochloride in saline; Other: Normal Saline (0.9% NaCl)

PLACEBO GROUP

EXPERIMENTAL

Preoperative gargle with 30 mL normal saline administered 5 minutes before induction.

Drug: Ketamine Hydrochloride in saline; Other: Normal Saline (0.9% NaCl)

Interventions

Ketamine Hydrochloride in saline DRUG

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.

KETAMINE GROUP; PLACEBO GROUP

Normal Saline (0.9% NaCl) OTHER

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.

KETAMINE GROUP; PLACEBO GROUP

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-12 years
• ASA physical status I-II
• Scheduled for elective adenotonsillectomy
• Ability to gargle and spit the study solution

You may not qualify if:

• Known hypersensitivity to ketamine
• Coagulation disorders
• History of neuropsychiatric disease
• Active upper respiratory tract infection

Sponsors & Collaborators

• Hospital Universitario de Caracas: lead

Study Sites (1)

VERAZA

Caracas, Miranda, 1040, Venezuela

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors were blinded to group allocation. Study solutions were prepared by an independent pharmacist not involved in patient care or outcome assessment to ensure allocation concealment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff of Anesthesiology Department

Model Details: Participants were randomized in a parallel 1:1 allocation to receive either a ketamine gargle or placebo prior to induction of anesthesia.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: January 10, 2024
• Primary Completion: January 7, 2025
• Study Completion: January 14, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

VE (1)