Dexmedetomidine Infusion in Hypospadias Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926705
• Other study ID #: alghanem2
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2009
• Last updated: June 22, 2009
• Start date: June 2008
• Est. completion date: January 2009

Study information

• Verified date: June 2009
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypospadias
• Pain

Intervention

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

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative and postoperative fentanyl requirement (in microg/kg)		6/2008-1/2009	No