Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy. | NCT06010927 | Trialant

Unknown statusInterventionalPhase 4Updated Sep 15, 2023

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.

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT06010927
Lead Sponsor: Cairo UniversityOTHER
Overall Status: Unknown status
Study Type: Interventional
Phase: Phase 4
Enrollment: 140Estimated
Last Update Posted: Sep 15, 2023Actual
Start Date: Aug 25, 2023Actual
Primary Completion Date: Nov 2023Estimated
Completion Date: Dec 2023Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

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

The medical conditions and diseases this study investigates.

Emergence Delirium

Interventions

The treatments and procedures being evaluated in this study.

ketamine/midazolam
Ketofol

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

Abeer AhmedContact

abeer_ahmed@kasralainy.edu.eg01005244590

Locations

Where the study is run and whether each site is currently recruiting.

Abeer AhmedRecruiting

Maadi, Cairo Governorate 11562, Egypt

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Cairo UniversityOTHER

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