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

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Cairo University (CU)

Status and phase

Enrolling
Phase 4

Conditions

Emergence Delirium

Treatments

Drug: Ketofol
Drug: ketamine/midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT06010927
MS-92-2023

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

3 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

Group-A; ketamine/midazolam premedication
Active Comparator group
Treatment:
Drug: ketamine/midazolam
Group-B: Ketofol pre-extubation
Active Comparator group
Treatment:
Drug: Ketofol

Trial contacts and locations

0

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Central trial contact

Abeer Ahmed

Data sourced from clinicaltrials.gov

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