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

Phase 4

Completed

• Conditions: Postoperative Pain, Acute; Emergence Delirium
• Interventions: Drug: ketamine; Drug: fentanyl

• Registration Number: NCT06630364
• Lead Sponsor: Medipol University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-06-15
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (Ketamine group)	ketamine	The patients in this group will have intravenous ketamine (0.5 mg/kg) during induction
Group II (Fentanyl Group)	fentanyl	The patients in this group will have intravenous fentanyl (1 µg/kg) during induction

Primary Outcome Measures

Name	Time	Method
Pain Scores	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.)

Secondary Outcome Measures

Name	Time	Method
Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy	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

Trial Locations

Locations (1)

Medipol Mega University Hospital; 🇹🇷 Istanbul, Bagcılar, Turkey