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

NCT06010927 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-09-15

No results posted yet for this 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.

Conditions

  • Emergence Delirium

Interventions

DRUG

ketamine/midazolam

premedication

DRUG

Ketofol

Pre-extubation

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06010927 on ClinicalTrials.gov