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

October 25, 2024 updated by: Yunus Oktay Atalay, Medipol University

A Randomized Clinical Trial Comparing Ketamine and Fentanyl for Postoperative Pain Management and Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bagcılar
      • Istanbul, Bagcılar, Turkey, 34214
        • Medipol Mega University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Study Population

Children aged 3-8 years, ASA I-III, undergoing tonsillectomy and adenoidectomy

Description

Inclusion Criteria:

  • Children aged 3 to 8 years
  • Scheduled for tonsillectomy and adenoidectomy
  • American Society of Anesthesiologists (ASA) Physical Status I-III

Exclusion Criteria:

  • American Society of Anesthesiologists' Physical Status ≥4
  • Known hypersensitivity or allergy to any of the study medications (acetaminophen, ketamine, fentanyl)
  • Receiving chronic opioid analgesic therapy prior to surgery
  • Renal disease
  • Hepatic disease
  • Obesity (body mass index greater than 99th percentile for age)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (Ketamine group)
The patients in this group will have intravenous ketamine (0.5 mg/kg) during induction
Drug: ketamine
Induction: Sevoflurane in N2O/O2, Propofol (1-1.5 mg/kg) Analgesia: Ketamine (0.5 mg/kg) Maintenance: Sevoflurane
Experimental: Group II (Fentanyl Group)
The patients in this group will have intravenous fentanyl (1 µg/kg) during induction
Drug: fentanyl
Induction: Sevoflurane in N2O/O2 Analgesia: Propofol (1-1.5 mg/kg), Fentanyl (1 µg/kg) Maintenance: Sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: From the enrollment to 8 hours post-surgery
Face, Legs, Activity, Cry, Consolability (FLACC) Scale Range: 0 to 10 Higher scores indicate worse pain 0 = no pain, 10 = worst possible pain (Assessment of Behavioural Score: ; 0 = Relaxed and comfortable ; 1-3 = Mild discomfort ; 4-6 = Moderate pain ; 7-10 = Severe discomfort/pain.)
From the enrollment to 8 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy
Time Frame: From the enrollment to 8 hours post-surgery
Pediatric Anesthesia Emergence Delirium (PAED) Scale Range: 0 to 20 Higher scores indicate more severe emergence delirium 0 = no delirium, 20 = extreme delirium
From the enrollment to 8 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Collaborators

Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-4354Karar651
  • Istanbul Medipol University (Other Identifier: Istanbul Medipol University Ethics Committee Decision No: 855/2021)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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