Dexmedetomidine Infusion in Hypospadias Surgery - Full Text View

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:

Drug Information available for: Fentanyl Fentanyl citrate Dexmedetomidine Dexmedetomidine hydrochloride

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
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

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
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
Epispadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Urethral Diseases
Urologic Diseases
Fentanyl
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics

Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on June 18, 2013