Clinical trial NCT06630364: Comparing Ketamine and Fentanyl in Pediatric Tonsillectomy: Pain Control and Emergence Delirium Outcomes (KVFPT)
Official title: A Randomized Clinical Trial Comparing Ketamine and Fentanyl for Postoperative Pain Management and Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain, Acute
Emergence Delirium
Keywords: Tonsillectomy, Adenoidectomy, Postoperative pain management, Emergence delirium, Ketamine, Fentanyl
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: Istanbul Medipol University Hospital
First posted: 2024-10-08
Enrollment: 59
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Pain Scores
timeFrame: From the enrollment to 8 hours post-surgery
Secondary outcomes:
measure: Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy
timeFrame: From the enrollment to 8 hours post-surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol Mega University Hospital
state: Bagcılar
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.