Back to resultsEffect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
Primary Purpose
Agitation, Emergence, Post Operative Pain
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nalbuphine
Bupivacain
Sponsored by
About this trial
This is an interventional prevention trial for Agitation, Emergence
Eligibility Criteria
Inclusion Criteria:
- Age 2_12 years
- Both genders
- ASA I_II
- Children undergoing infra-umbilical surgeries
Exclusion Criteria:
- Guardians refusal
- congenital anomalies at the lower spine or meringues
- Increased intracranial pressure
- Skin infection at site of injection
- Bleeding diathesis
- Known allergy to any drugs used
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nalbuphine
Bupivacaine
Arm Description
Outcomes
Primary Outcome Measures
Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
PAED ( The pediatric anesthesia emergence delirium scale)
Secondary Outcome Measures
Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05245721
Brief Title
Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
Official Title
Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Emergence, Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nalbuphine
Arm Type
Active Comparator
Arm Title
Bupivacaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Intervention Description
Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries
Primary Outcome Measure Information:
Title
Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
Description
PAED ( The pediatric anesthesia emergence delirium scale)
Time Frame
Up to 2 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)
Time Frame
For 24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 2_12 years
Both genders
ASA I_II
Children undergoing infra-umbilical surgeries
Exclusion Criteria:
Guardians refusal
congenital anomalies at the lower spine or meringues
Increased intracranial pressure
Skin infection at site of injection
Bleeding diathesis
Known allergy to any drugs used
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab Adel Ebrahim
Phone
01099070718
Email
Adelrehab273@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Fathy Mostafa, Assistant professor
Phone
01001123062
Email
mo7_fathy@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
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