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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain, Acute Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (Ketamine group)

The patients in this group will have intravenous ketamine (0.5 mg/kg) during induction

Group Type ACTIVE_COMPARATOR

ketamine

Intervention Type DRUG

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

Group II (Fentanyl Group)

The patients in this group will have intravenous fentanyl (1 µg/kg) during induction

Group Type EXPERIMENTAL

fentanyl

Intervention Type DRUG

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

Interventions

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ketamine

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

Intervention Type DRUG

fentanyl

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No