NCT06630364

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-05-01
• Completion: 2024-06-15
• First posted: 2024-10-08
• Last updated: 2024-10-30

Locations

1 site across 1 country: Turkey (Türkiye)