Dexmedetomidine Infusion in Hypospadias Surgery

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Dexmedetomidine and Fentanyl; Drug: Fentanyl

• Registration Number: NCT00926705
• Lead Sponsor: University of Jordan

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

Not available

Study Timeline

• Study Start: 2008-06
• Study Completion: 2009-01
• Status Verified: 2009-06
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-22
• Last Update Submitted: 2009-06-22
• Study First Posted: 2009-06-23
• Last Update Posted: 2009-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine and Fentanyl	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.
Fentanyl	Fentanyl	This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.

Primary Outcome Measures

Name	Time	Method
Intraoperative and postoperative fentanyl requirement (in microg/kg)	6/2008-1/2009

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Jordan