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Ketamine Gargle for Pain After Pediatric Tonsillectomy (KET-TONSIL)

29. april 2026 opdateret af: Joseph Alejandro Veraza Almeida, Hospital Universitario de Caracas

Preemptive Topical Ketamine for Post-Tonsillectomy Analgesia: A Randomized, Double-Blind, Placebo-Controlled Trial in Children

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Adenotonsillectomy is one of the most frequently performed surgical procedures in pediatric patients and is associated with significant postoperative pain. Effective analgesia remains challenging due to the need to balance efficacy with safety, particularly avoiding opioid-related respiratory complications. Topical ketamine, a non-competitive NMDA receptor antagonist, has been proposed as a peripheral analgesic strategy capable of reducing nociceptive signaling without significant systemic effects.

This study was designed as a prospective, randomized, double-blind, placebo-controlled trial conducted at a tertiary care center. A total of 420 pediatric patients (ASA I-II, aged 4-12 years) scheduled for elective adenotonsillectomy were enrolled. Participants were randomized in a 1:1 ratio to receive either a ketamine gargle (40 mg diluted in 30 mL saline) or a placebo saline gargle administered 5 minutes before induction of anesthesia.

All patients underwent standardized anesthetic and surgical protocols to minimize confounding variables. Pain intensity was assessed using the Visual Analog Scale at 0, 4, 8, 12, and 24 hours postoperatively. Secondary outcomes included incidence of postoperative hemorrhage requiring surgical reintervention, total rescue analgesic consumption, and adverse events such as nausea, vomiting, sedation, or psychomimetic effects.

The primary objective was to evaluate the analgesic efficacy of preemptive topical ketamine. Secondary analyses explored its potential impact on postoperative morbidity, particularly bleeding events. This study was conducted in accordance with ethical standards and CONSORT guidelines.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

420

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Venezuela
    • Miranda
      • Caracas, Miranda, Venezuela, 1040
        • VERAZA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Exclusion Criteria:

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: KETAMINE GROUP
Preoperative gargle with 40 mg ketamine diluted in 30 mL saline, administered 5 minutes before induction of anesthesia.
Medicin: 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.
Andet: 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.
Eksperimentel: PLACEBO GROUP
Preoperative gargle with 30 mL normal saline administered 5 minutes before induction.
Medicin: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative pain intensity
Tidsramme: 0, 4, 8, 12, and 24 hours postoperatively
Pain intensity measured using the Visual Analog Scale (VAS; 0-10) at predefined postoperative time points.
0, 4, 8, 12, and 24 hours postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative hemorrhage requiring surgical reintervention
Tidsramme: Within 24 hours postoperatively
Incidence of postoperative bleeding requiring return to the operating room for hemostasis.
Within 24 hours postoperatively
Rescue analgesic consumption
Tidsramme: 24 hours postoperatively
Total requirement of additional analgesics (e.g., paracetamol or NSAIDs) within the first 24 hours after surgery.
24 hours postoperatively
Adverse events
Tidsramme: 24 hours postoperatively
Incidence of postoperative nausea and vomiting, sedation, or psychomimetic effects such as hallucinations or dysphoria.
24 hours postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital Universitario de Caracas

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. januar 2024

Primær færdiggørelse (Faktiske)

7. januar 2025

Studieafslutning (Faktiske)

14. januar 2025

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KET-AT-2024-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Individual participant data (IPD) sharing has not yet been determined. Data may be made available upon reasonable request to the corresponding author following publication, in accordance with institutional policies and applicable ethical regulations.

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Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Ketamine Hydrochloride in saline

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