Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02618876

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

2 groups, 30 patients each

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Nalbuphine plus Bupivacaine Drug: Bupivacaine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nalbuphine group 30 children will be given Caudal Bupivacaine plus Nalbuphine.	Drug: Nalbuphine plus Bupivacaine Addition of caudal Nalbuphine to the standard Bupivacaine
Other: Control group 30 children will be given Caudal Bupivacaine.	Drug: Bupivacaine Caudal Bupivacaine is the standard of care will be considered as a control

Arm

Intervention/Treatment

Active Comparator: Nalbuphine group

30 children will be given Caudal Bupivacaine plus Nalbuphine.

Drug: Nalbuphine plus Bupivacaine

Addition of caudal Nalbuphine to the standard Bupivacaine

Other: Control group

30 children will be given Caudal Bupivacaine.

Drug: Bupivacaine

Caudal Bupivacaine is the standard of care will be considered as a control

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Cortisol level [6 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospital	Assiut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Bakri, Associate professor, Assiut University

ClinicalTrials.gov Identifier:

NCT02618876

Other Study ID Numbers:

IRB 000087145

First Posted:

Dec 2, 2015

Last Update Posted:

Apr 7, 2020

Last Verified:

Apr 1, 2020

Additional relevant MeSH terms:

Pain, Postoperative

Nalbuphine

Bupivacaine

Study Results

No Results Posted as of Apr 7, 2020