NCT06010927

Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.

Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

An optimum recovery profile after AT includes a rapid, smooth awakening without emergence agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate receptor antagonist with good analgesic properties and periprocedural amnesia. The ketamine/midazolam combination was administered in different ways with controversial results about their effect on the EA and recovery profile. Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery profiles regarding postoperative EA and PONV. This study aims to evaluate the effect of premedication with an intramuscular ketamine/ midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.

Conditions

• Emergence Delirium

Interventions

Type	Name	Description
DRUG	ketamine/midazolam	premedication
DRUG	Ketofol	Pre-extubation

Timeline

• Start date: 2023-08-25
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2023-08-25
• Last updated: 2023-09-15

Locations

2 sites across 1 country: Egypt