Comparing Dexmedetomidine With Bupivacaine Versus Bupivacaine Alone for Caudal Block in Supra - Umbilical Surgeries

July 16, 2018 updated by: Ahmed Kareem, Cairo University

Adding Dexmedetomidine to Caudal Bupivacaine for Analgesia in Supra - Umbilical Pediatric Surgeries: Would it Add More Analgesia

dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically or combined to local anesthetics during regional blocks. Investigators studied the combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in pediatric patients undergoing supra - umbilical surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dexmedetomidine was combined to bupivavaine and administered via caudal route to be compared to caudal bupivavaine alone for analgesia following upper trunk surgery

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 3

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
      • Cairo, Egypt
        • Cairo University

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

1 year to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • supra - umbilical surgeries

Exclusion Criteria:

  • allergy to the drug or coagulopathy

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: D group
Dexmedetomidine with bupivacaine group Caudal dexmedetomidine 1.5 microgram/kg with bupivavaine (0.25%) 1.25 ml/kg were administered
Drug: Dexmedetomidine
Caudal block by dexmedetomidine and bupivavaine
Other Names:
  • Precedex
ACTIVE_COMPARATOR: B group
Bupivacaine only group Caudal bupivavaine (0.25%) 1.25 ml/kg without dexmedetomidine was administered
Drug: Bupivacaine
Caudal block by bupivavaine alone
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 6 months study
CHEOPS scale value
6 months study

Collaborators and Investigators

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

Sponsor

Cairo 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 (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

December 30, 2017

Study Completion (ACTUAL)

December 30, 2017

Study Registration Dates

First Submitted

August 20, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (ACTUAL)

October 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Caudaldexsupraumblical

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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 Anesthesia

Clinical Trials on Dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe