Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Nalbuphine plus Bupivacaine; Drug: Bupivacaine

• Registration Number: NCT02618876
• Lead Sponsor: Assiut University

Brief Summary

Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair.

2 groups, 30 patients each

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-29
• Study First Posted: 2015-12-02
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nalbuphine group	Nalbuphine plus Bupivacaine	30 children will be given Caudal Bupivacaine plus Nalbuphine.
Control group	Bupivacaine	30 children will be given Caudal Bupivacaine.

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale	During 24 h in the postoperative period

Secondary Outcome Measures

Name	Time	Method
Cortisol level	6 hours

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt