Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedFebruary 18, 2022
February 1, 2022
10 months
January 18, 2022
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
PAED ( The pediatric anesthesia emergence delirium scale)
Up to 2 hours postoperative
Secondary Outcomes (1)
Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)
For 24 hours postoperative
Study Arms (2)
Nalbuphine
ACTIVE COMPARATORBupivacaine
ACTIVE COMPARATORInterventions
Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries
Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries
Eligibility Criteria
You may qualify if:
- Age 2\_12 years
- Both genders
- ASA I\_II
- Children undergoing infra-umbilical surgeries
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
January 18, 2022
First Posted
February 18, 2022
Study Start
March 1, 2022
Primary Completion
January 1, 2023
Study Completion
February 1, 2023
Last Updated
February 18, 2022
Record last verified: 2022-02