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

NCT06630364 | Completed Phase 4

• 2 other identifiers: E-10840098-772.02-4354Karar651Istanbul Medipol University
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute; Emergence Delirium

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  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.)

  From the enrollment to 8 hours post-surgery

Secondary Outcomes (1)

• Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy

  From the enrollment to 8 hours post-surgery

Study Arms (2)

Group I (Ketamine group)

ACTIVE COMPARATOR

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

Drug: ketamine

Group II (Fentanyl Group)

EXPERIMENTAL

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

Drug: fentanyl

Interventions

ketamine DRUG

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

Group I (Ketamine group)

fentanyl DRUG

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

Group II (Fentanyl Group)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 8 years
• Scheduled for tonsillectomy and adenoidectomy
• American Society of Anesthesiologists (ASA) Physical Status I-III

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medipol University: lead
• Istanbul Medipol University Hospital: collaborator

Study Sites (1)

Medipol Mega University Hospital

Istanbul, Bagcılar, 34214, Turkey (Türkiye)

Location

Related Publications (4)

• Abdelhalim AA, Alarfaj AM. The effect of ketamine versus fentanyl on the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Saudi J Anaesth. 2013 Oct;7(4):392-8. doi: 10.4103/1658-354X.121047.

  PMID: 24348289 BACKGROUND

• Michelet D, Hilly J, Skhiri A, Abdat R, Diallo T, Brasher C, Dahmani S. Opioid-Sparing Effect of Ketamine in Children: A Meta-Analysis and Trial Sequential Analysis of Published Studies. Paediatr Drugs. 2016 Dec;18(6):421-433. doi: 10.1007/s40272-016-0196-y.

  PMID: 27688125 BACKGROUND

• Eghbal MH, Taregh S, Amin A, Sahmeddini MA. Ketamine improves postoperative pain and emergence agitation following adenotonsillectomy in children. A randomized clinical trial. Middle East J Anaesthesiol. 2013 Jun;22(2):155-60.

  PMID: 24180163 BACKGROUND

• Alghamdi F, Roth C, Jatana KR, Elmaraghy CA, Rice J, Tobias JD, Thung AK. Opioid-Sparing Anesthetic Technique for Pediatric Patients Undergoing Adenoidectomy: A Pilot Study. J Pain Res. 2020 Nov 19;13:2997-3004. doi: 10.2147/JPR.S281275. eCollection 2020.

  PMID: 33239908 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Emergence Delirium

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Prof, DESAIC

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: January 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 15, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)