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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06630364

Acronym

KVFPT

Enrollment

Registered

2024-10-08

Start date

2023-01-01

Completion date

2024-06-15

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Postoperative Pain, Acute

Keywords

Tonsillectomy, Adenoidectomy, Postoperative pain management, Emergence delirium, Ketamine, Fentanyl

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.

Interventions

DRUGketamine

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

DRUGfentanyl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 8 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026