Dexmedetomidine Infusion in Hypospadias Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

June 22, 2009

Last Updated Date

June 22, 2009

Start Date ^ICMJE

June 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Intraoperative and postoperative fentanyl requirement (in microg/kg) [ Time Frame: 6/2008-1/2009 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dexmedetomidine Infusion in Hypospadias Surgery

Official Title ^ICMJE

An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Dexmedetomidine and Fentanyl
Drug: Fentanyl

Study Arms / Comparison Groups

Active Comparator: This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

1 Year to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Jordan

Administrative Information

NCT ID ^ICMJE

NCT00926705

Responsible Party

University of Jordan

Study ID Numbers ^ICMJE

alghanem2

Study Sponsor ^ICMJE

University of Jordan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Khaled R Al-Zaben, MD

University of Jordan

Information Provided By

University of Jordan

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP