Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

Postoperative Pain Clinical Trial

Official title:

Nalbuphine as an Adjuvant to Caudal Bupivacaine for Postoperative Analgesia in Children Undergoing Hypospadias Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618876
• Other study ID #: IRB 000087145
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

2 groups, 30 patients each

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Nalbuphine plus Bupivacaine
Addition of caudal Nalbuphine to the standard Bupivacaine
• Bupivacaine
Caudal Bupivacaine is the standard of care will be considered as a control

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale		During 24 h in the postoperative period
Secondary	Cortisol level		6 hours