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

Phase 1

• Conditions: Agitation, Emergence; Post Operative Pain
• Interventions: Drug: Nalbuphine; Drug: Bupivacain

• Registration Number: NCT05245721
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-08
• Last Update Submitted: 2022-02-08
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18
• Study Start: 2022-03
• Primary Completion: 2023-01
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nalbuphine	Bupivacain	-
Bupivacaine	Bupivacain	-
Nalbuphine	Nalbuphine	-

Primary Outcome Measures

Name	Time	Method
Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)	Up to 2 hours postoperative	PAED ( The pediatric anesthesia emergence delirium scale)

Secondary Outcome Measures

Name	Time	Method
Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)	For 24 hours postoperative