Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

NCT ID: NCT02618876

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-12-31

Brief Summary

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

2 groups, 30 patients each

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nalbuphine group

30 children will be given Caudal Bupivacaine plus Nalbuphine.

Group Type ACTIVE_COMPARATOR

Nalbuphine plus Bupivacaine

Intervention Type DRUG

Addition of caudal Nalbuphine to the standard Bupivacaine

Control group

30 children will be given Caudal Bupivacaine.

Group Type OTHER

Bupivacaine

Intervention Type DRUG

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

Interventions

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Nalbuphine plus Bupivacaine

Addition of caudal Nalbuphine to the standard Bupivacaine

Intervention Type DRUG

Bupivacaine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Bakri

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB 000087145

Identifier Type: -

Identifier Source: org_study_id

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