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Dexmedetomidine Infusion in Hypospadias Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926705
First Posted: June 23, 2009
Last Update Posted: June 23, 2009
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:
University of Jordan
  Purpose
The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for intraoperative and postoperative analgesia.

Condition Intervention Phase
Pain Drug: Dexmedetomidine and Fentanyl Drug: Fentanyl Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery

Resource links provided by NLM:


Further study details as provided by University of Jordan:

Primary Outcome Measures:
  • Intraoperative and postoperative fentanyl requirement (in microg/kg) [ Time Frame: 6/2008-1/2009 ]

Enrollment: 48
Study Start Date: June 2008
Study Completion Date: January 2009
Arms Assigned Interventions
Active Comparator: Fentanyl
This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
Drug: Fentanyl
This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
Experimental: Dexmedetomidine and Fentanyl
This group received a combination of Dexmedetomidine (1 ug/kg) and Fentanyl (1.79 ug/kg). Total number of patients in this group 24.
Drug: Dexmedetomidine and Fentanyl
Dexmedetomidine in a dose of 1 ug/kg initial dose then continuous infusion of 0.7 ug/kg/hr . Combined with Fentanyl at a dose of 2 ug/kg initially plus boluses of fentanyl to keep the patient hemodynamically stable.
Other Name: Precedex

  Eligibility

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 1-12 years undergoing hypospadias repair

Exclusion Criteria:

  • Allergy to Dexmedetomidine
  • Preoperative use of sedatives or analgesics
  • cardiac diseases
  • Children with mental retardation
  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): NCT00926705


Locations
Jordan
Jordan University Hospital
Amman, Jordan, 11942
Sponsors and Collaborators
University of Jordan
Investigators
Study Chair: Khaled R Al-Zaben, MD University of Jordan
  More Information

Publications:
Responsible Party: University of Jordan
ClinicalTrials.gov Identifier: NCT00926705     History of Changes
Other Study ID Numbers: alghanem2
First Submitted: June 22, 2009
First Posted: June 23, 2009
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by University of Jordan:
Dexmedetomidine
Fentanyl
Pain
Pediatrics

Additional relevant MeSH terms:
Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Dexmedetomidine
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics