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Dexmedetomidine Infusion in Hypospadias Surgery

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
Jordan
Study Type
Interventional
Intervention
Dexmedetomidine and Fentanyl
Fentanyl
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Dexmedetomidine, Fentanyl, Pain, Pediatrics

Eligibility Criteria

1 Year - 12 Years (Child)MaleDoes not accept 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

Sites / Locations

  • Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fentanyl

Dexmedetomidine and Fentanyl

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intraoperative and postoperative fentanyl requirement (in microg/kg)

Secondary Outcome Measures

Full Information

First Posted
June 22, 2009
Last Updated
June 22, 2009
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT00926705
Brief Title
Dexmedetomidine Infusion in Hypospadias Surgery
Official Title
An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Jordan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Dexmedetomidine, Fentanyl, Pain, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
Arm Title
Dexmedetomidine and Fentanyl
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine and Fentanyl
Other Intervention Name(s)
Precedex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
Primary Outcome Measure Information:
Title
Intraoperative and postoperative fentanyl requirement (in microg/kg)
Time Frame
6/2008-1/2009

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled R Al-Zaben, MD
Organizational Affiliation
University of Jordan
Official's Role
Study Chair
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Citations:
PubMed Identifier
2900154
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. doi: 10.1016/0014-2999(88)90744-3.
Results Reference
result
PubMed Identifier
16803911
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. doi: 10.1007/BF03021622.
Results Reference
result
PubMed Identifier
14693611
Citation
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):153-158. doi: 10.1213/01.ANE.0000093225.39866.75.
Results Reference
result
PubMed Identifier
15180019
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. doi: 10.1097/00007611-200405000-00007.
Results Reference
result
PubMed Identifier
14693585
Citation
Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.
Results Reference
result

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Dexmedetomidine Infusion in Hypospadias Surgery

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