Back to resultsDexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair
Primary Purpose
Preemptive Analgesia, Dexmedetomidine, Ketamine
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Ketamine
Magnesium sulphate
Sponsored by
About this trial
This is an interventional treatment trial for Preemptive Analgesia
Eligibility Criteria
Inclusion Criteria: Aged 1-7 years American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair. Exclusion Criteria: Developmental delay Psychological or neurological disorders Difficult airway Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
Sites / Locations
- Karelsheikh University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dexmedetomidine
Ketamine
Magnesium sulphate
Arm Description
0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.
Outcomes
Primary Outcome Measures
First time of rescue analgesia requirement
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The first time to require analgesia will be calculated (the time from caudal block to the first time to pethidine injection).
Secondary Outcome Measures
Total consumption of rescue analgesia
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The total pethidine consumption of patients require analgesia in the first 24 h postoperative will be calculated.
Pain score
FLACC scale will used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain
The incidence of adverse effects
Hypotension bradycardia, respiratory depression and vomiting will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05837000
Brief Title
Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair
Official Title
Role of Adding Dexmedetomidine, Ketamine and Magnesium Sulphate to Caudal Block as Preemptive Analgesia in Hypospadias Repair in Pediatrics: a Randomized Double-blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
October 25, 2024 (Anticipated)
Study Completion Date
October 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preemptive Analgesia, Dexmedetomidine, Ketamine, Magnesium Sulphate, Hypospadias, Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
Arm Title
Magnesium sulphate
Arm Type
Experimental
Arm Description
0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Patient will receive 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally
Intervention Type
Drug
Intervention Name(s)
Magnesium sulphate
Intervention Description
Patient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.
Primary Outcome Measure Information:
Title
First time of rescue analgesia requirement
Description
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The first time to require analgesia will be calculated (the time from caudal block to the first time to pethidine injection).
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Total consumption of rescue analgesia
Description
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The total pethidine consumption of patients require analgesia in the first 24 h postoperative will be calculated.
Time Frame
24 hours postoperatively
Title
Pain score
Description
FLACC scale will used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain
Time Frame
24 hours postoperatively
Title
The incidence of adverse effects
Description
Hypotension bradycardia, respiratory depression and vomiting will be recorded.
Time Frame
24 hours postoperatively
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
males
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 1-7 years
American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.
Exclusion Criteria:
Developmental delay
Psychological or neurological disorders
Difficult airway
Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal MD Hendawy Shams, MD
Phone
00201095927971
Email
gamal.shams@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kafrelsheikh University
Organizational Affiliation
Research ethics committee - Kafrelsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karelsheikh University Hospital
City
Kafr Ash Shaykh
State/Province
Karelsheikh
ZIP/Postal Code
33516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamal H Shams, MD
Phone
00201095927971
Email
gamal.shams@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon Reasonable request from the corresponding author for one year after study completion
IPD Sharing Time Frame
The data will be available for one year after study completion
IPD Sharing Access Criteria
The data will be available upon Reasonable request from the corresponding author.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://kfs.edu.eg/engkfs/
Available IPD/Information Identifier
MKSU 51- 2 _ 16
Learn more about this trial
Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair
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