Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

April 6, 2020 updated by: Mohamed Bakri, Assiut University

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

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

2 groups, 30 patients each

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Cortisol level
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 29, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 000087145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Nalbuphine plus Bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe