Dexmedetomidine Infusion in Hypospadias Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Jordan
ClinicalTrials.gov Identifier:
NCT00926705
First received: June 22, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Year to 12 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 22, 2009
Last Updated: June 22, 2009
Health Authority: Jordan: Ethical Committee

Keywords provided by University of Jordan:
Dexmedetomidine
Fentanyl
Pain
Pediatrics

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

ClinicalTrials.gov processed this record on August 18, 2014