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

M

Medipol University

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain, Acute
Emergence Delirium

Treatments

Drug: fentanyl
Drug: ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT06630364
E-10840098-772.02-4354Karar651
Istanbul Medipol University

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

3 to 8 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

59 participants in 2 patient groups

Group I (Ketamine group)
Active Comparator group
Description:
The patients in this group will have intravenous ketamine (0.5 mg/kg) during induction
Treatment:
Drug: ketamine
Group II (Fentanyl Group)
Experimental group
Description:
The patients in this group will have intravenous fentanyl (1 µg/kg) during induction
Treatment:
Drug: fentanyl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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