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NCT05245721 Clinical Trial

Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries

Post Operative Pain Clinical Trial

Official title:
Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05245721
Other study ID # 17101501
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date March 2022
Est. completion date February 2023

Study information
Verified date February 2022
Source Assiut University
Contact Rehab Adel Ebrahim
Phone 01099070718
Email Adelrehab273@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date February 2023
Est. primary completion date January 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 12 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nalbuphine
Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries
• Bupivacain
Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS) For 24 hours postoperative
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