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

Primary Purpose

Emergence Delirium

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
ketamine/midazolam
Ketofol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Abeer AhmedRecruiting
  • Anesthesia department - Faculty of medicine- Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group-A; ketamine/midazolam premedication

Group-B: Ketofol pre-extubation

Arm Description

Outcomes

Primary Outcome Measures

incidence of Emergence agitation

Secondary Outcome Measures

Full Information

First Posted
June 28, 2023
Last Updated
September 14, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06010927
Brief Title
Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.
Official Title
Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-A; ketamine/midazolam premedication
Arm Type
Active Comparator
Arm Title
Group-B: Ketofol pre-extubation
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ketamine/midazolam
Intervention Description
premedication
Intervention Type
Drug
Intervention Name(s)
Ketofol
Intervention Description
Pre-extubation
Primary Outcome Measure Information:
Title
incidence of Emergence agitation
Time Frame
starting from time of PACU admission after recover from anesthesia till 6 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abeer Ahmed
Phone
01005244590
Email
abeer_ahmed@kasralainy.edu.eg
Facility Information:
Facility Name
Abeer Ahmed
City
Maadi
State/Province
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abeer Ahmed
Phone
01005244590
Email
abeer_ahmed@kasralainy.edu.eg
Facility Name
Anesthesia department - Faculty of medicine- Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abeer Ahmed, Anesthesia lecturer

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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