NCT00926705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
Last Updated

June 23, 2009

Status Verified

June 1, 2009

First QC Date

June 22, 2009

Last Update Submit

June 22, 2009

Conditions

Pain

Keywords

DexmedetomidineFentanylPainPediatrics

Outcome Measures

Primary Outcomes (1)

  • Intraoperative and postoperative fentanyl requirement (in microg/kg)

    6/2008-1/2009

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

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

Drug: Fentanyl

Dexmedetomidine and Fentanyl

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.

Drug: Dexmedetomidine and Fentanyl

Interventions

Dexmedetomidine and FentanylDRUG

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.

Also known as: Precedex
Dexmedetomidine and Fentanyl
FentanylDRUG

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

Fentanyl

Eligibility Criteria

Age1 Year - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 1-12 years undergoing hypospadias repair

You may not qualify if:

  • Allergy to Dexmedetomidine
  • Preoperative use of sedatives or analgesics
  • cardiac diseases
  • Children with mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University Hospital

Amman, 11942, Jordan

Location

Related Publications (5)

  • 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.

    PMID: 2900154RESULT

  • 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.

    PMID: 16803911RESULT

  • 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.

    PMID: 14693611RESULT

  • 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.

    PMID: 15180019RESULT

  • 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.

    PMID: 14693585RESULT

MeSH Terms

Conditions

Pain

Interventions

DexmedetomidineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Officials

  • Khaled R Al-Zaben, MD

    University of Jordan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

June 1, 2008

Study Completion

January 1, 2009

Last Updated

June 23, 2009

Record last verified: 2009-06

Locations

JO(1)