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

Last updated: September 14, 2023
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

ketamine/midazolam

Ketofol

Clinical Study ID

NCT06010927
MS-92-2023
  • Ages 3-10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA physical status I or II
  • Children scheduled for AT under general anesthesia (GA).

Exclusion

Exclusion Criteria:

  • Congenital cardiovascular anomalies
  • Behavioral changes
  • Delayed physical development
  • Children receiving sedatives or anticonvulsants therapy

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: ketamine/midazolam
Phase: 4
Study Start date:
August 25, 2023
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Abeer Ahmed

    Maadi, Cairo 11562
    Egypt

    Active - Recruiting

  • Anesthesia department - Faculty of medicine- Cairo University

    Cairo,
    Egypt

    Active - Recruiting

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