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
About this trial
This is an interventional prevention trial for Emergence Delirium
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
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
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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