Back to resultsEffect of Caudal Nalbuphine on Postoperative Analgesia in Children
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nalbuphine plus Bupivacaine
Bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Children undergoing elective Hypospadias repair
- with American Society of Anesthesiologists (ASA) physical status I
- age 2-10 years
Exclusion Criteria:
- Coagulation disorder
- allergy to study medications
- major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Nalbuphine group
Control group
Arm Description
30 children will be given Caudal Bupivacaine plus Nalbuphine.
30 children will be given Caudal Bupivacaine.
Outcomes
Primary Outcome Measures
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale
Secondary Outcome Measures
Cortisol level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02618876
Brief Title
Effect of Caudal Nalbuphine on Postoperative Analgesia in Children
Official Title
Nalbuphine as an Adjuvant to Caudal Bupivacaine for Postoperative Analgesia in Children Undergoing Hypospadias Repair
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair.
2 groups, 30 patients each
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nalbuphine group
Arm Type
Active Comparator
Arm Description
30 children will be given Caudal Bupivacaine plus Nalbuphine.
Arm Title
Control group
Arm Type
Other
Arm Description
30 children will be given Caudal Bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Nalbuphine plus Bupivacaine
Intervention Description
Addition of caudal Nalbuphine to the standard Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Caudal Bupivacaine is the standard of care will be considered as a control
Primary Outcome Measure Information:
Title
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale
Time Frame
During 24 h in the postoperative period
Secondary Outcome Measure Information:
Title
Cortisol level
Time Frame
6 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children undergoing elective Hypospadias repair
with American Society of Anesthesiologists (ASA) physical status I
age 2-10 years
Exclusion Criteria:
Coagulation disorder
allergy to study medications
major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
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Effect of Caudal Nalbuphine on Postoperative Analgesia in Children
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