Dexmedetomidine Infusion in Hypospadias Surgery

University of Jordan

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Dexmedetomidine and Fentanyl; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT00926705

alghanem2

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Fentanyl

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl

Dexmedetomidine and Fentanyl

Experimental group

Description:

This group received a combination of Dexmedetomidine (1 ug/kg) and Fentanyl (1.79 ug/kg). Total number of patients in this group 24.

Treatment:

Drug: Dexmedetomidine and Fentanyl