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

This study has suspended participant recruitment.
(awaiting subjects and waiting for supply of the drug under investigation)
Sponsor:
ClinicalTrials.gov Identifier:
NCT03307590
First Posted: October 11, 2017
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahmed Kareem, Cairo University
  Purpose
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.

Condition Intervention Phase
Anesthesia Drug: Dexmedetomidine Drug: Bupivacaine Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adding Dexmedetomidine to Caudal Bupivacaine for Analgesia in Supra - Umbilical Pediatric Surgeries: Would it Add More Analgesia

Resource links provided by NLM:


Further study details as provided by Ahmed Kareem, Cairo University:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 6 months study ]
    CHEOPS scale value


Enrollment: 24
Actual Study Start Date: October 1, 2017
Estimated Study Completion Date: December 30, 2017
Estimated Primary Completion Date: December 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Marcaine

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • supra - umbilical surgeries

Exclusion Criteria:

  • allergy to the drug or coagulopathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307590


Locations
Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
  More Information

Responsible Party: Ahmed Kareem, Anesthesiologist, Cairo University
ClinicalTrials.gov Identifier: NCT03307590     History of Changes
Other Study ID Numbers: Caudaldexsupraumblical
First Submitted: August 20, 2017
First Posted: October 11, 2017
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Bupivacaine
Dexmedetomidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action