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Comparing Ketamine and Fentanyl in Pediatric Tonsillectomy: Pain Control and Emergence Delirium Outcomes (KVFPT)

NCT06630364 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-10-30

No results posted yet for this study

Summary

This study is designed to compare the effectiveness of two medications, ketamine and fentanyl, in managing pain and preventing delirium in children aged 3 to 8 years who are undergoing tonsillectomy and adenoidectomy surgery. The study aims to determine which medication is better at reducing pain and preventing delirium after surgery, and which one results in faster recovery times and fewer side effects. Children participating in the study will be randomly assigned to receive either ketamine or fentanyl during their surgery. The study will measure pain levels, recovery times, and any side effects experienced by the children. The results of this study will help doctors and anesthesiologists make better decisions about which medication to use for pain management in children undergoing tonsillectomy and adenoidectomy.

Conditions

  • Postoperative Pain, Acute
  • Emergence Delirium

Interventions

DRUG

ketamine

Induction: Sevoflurane in N2O/O2, Propofol (1-1.5 mg/kg) Analgesia: Ketamine (0.5 mg/kg) Maintenance: Sevoflurane

DRUG

fentanyl

Induction: Sevoflurane in N2O/O2 Analgesia: Propofol (1-1.5 mg/kg), Fentanyl (1 µg/kg) Maintenance: Sevoflurane

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    collaborator OTHER

  • Medipol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-05-01
Completion
2024-06-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

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 NCT06630364 on ClinicalTrials.gov