Dexmedetomidine Infusion in Hypospadias Surgery - Full Text View

Sponsor:	University of Jordan
Information provided by:	University of Jordan
ClinicalTrials.gov Identifier:	NCT00926705

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study
Official Title:	An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride Fentanyl Fentanyl Citrate

U.S. FDA Resources

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
Fentanyl: Active Comparator 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.
Dexmedetomidine and Fentanyl: Experimental 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.

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

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:

Virtanen R, Savola JM, Saano V, Nyman L. Characterization of the selectivity, specificity and potency of medetomidine as an alpha 2-adrenoceptor agonist. Eur J Pharmacol. 1988 May 20;150(1-2):9-14.

Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52.

Arain SR, Ruehlow RM, Uhrich TD, Ebert TJ. The efficacy of dexmedetomidine versus morphine for postoperative analgesia after major inpatient surgery. Anesth Analg. 2004 Jan;98(1):153-8, table of contents.

Tobias JD, Berkenbosch JW. Sedation during mechanical ventilation in infants and children: dexmedetomidine versus midazolam. South Med J. 2004 May;97(5):451-5.

Ibacache ME, Muñoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-3, table of contents.

Responsible Party:	University of Jordan
Study ID Numbers:	alghanem2
Study First Received:	June 22, 2009
Last Updated:	June 22, 2009
ClinicalTrials.gov Identifier:	NCT00926705 History of Changes
Health Authority:	Jordan: Ethical Committee

Keywords provided by University of Jordan:

Dexmedetomidine
Fentanyl
Pain
Pediatrics

Additional relevant MeSH terms:

Neurotransmitter Agents
Fentanyl
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Anesthetics
Adrenergic Agonists
Hypospadias
Urogenital Abnormalities
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Dexmedetomidine
Analgesics

Congenital Abnormalities
Analgesics, Opioid
Anesthetics, Intravenous
Adrenergic alpha-Agonists
Central Nervous System Depressants
Narcotics
Genital Diseases, Male
Penile Diseases
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009