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NCT Number: NCT06630364

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

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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Key information

Conditions

Postoperative Pain, Acute Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medipol Mega University Hospital

Istanbul, Bagcılar, 34214, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ketamine

Drug

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

Fentanyl

Drug

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

Primary outcomes

  1. Pain Scores

    Time frame: 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 outcomes

  1. Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Collaborators

  • Istanbul Medipol University Hospital

Registry information

Official study title

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

Acronym: KVFPT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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