Dexmedetomidine vs Fentanyl for BMT - Full Text View

Sponsor:	Children's Research Institute
Collaborator:	Hospira, Inc.
Information provided by:	Children's Research Institute
ClinicalTrials.gov Identifier:	NCT00654329

Purpose

A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.

Condition	Intervention	Phase
Otitis	Drug: Saline Drug: Fentanyl Drug: Dexmedetomidine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)

Resource links provided by NLM:

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Children's Research Institute:

Primary Outcome Measures:

Incidence of Pain [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

Secondary Outcome Measures:

Length of Stay in PACU [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
Total time from PACU entry until discharge

Enrollment:	101
Study Start Date:	August 2005
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dexmedetomidine 1microgram/kilogram Dexmedetomidine 1microgram/kilogram intranasal	Drug: Dexmedetomidine Dexmedetomidine, transmucosal, 1 microgram/kilogram Other Name: Precedex
Experimental: Dexmedetomidine 2 micrograms/kilogram Dexmedetomidine 2 micrograms/kilogram intranasal	Drug: Dexmedetomidine Dexmedetomidine, 2 microgram/kilogram, transmucosal route Other Name: Precedex
Active Comparator: Fentanyl 2 micrograms/kilogram Fentanyl 2 micrograms/kilogram intranasal	Drug: Fentanyl Fentanyl, nasal transmucosal, 2 micrograms/kilogram Other Name: Actiq, Fentora
Placebo Comparator: Normal saline placebo Normal saline placebo intranasal	Drug: Saline Normal saline, given intranasally Other Name: Normal Saline

Eligibility

Ages Eligible for Study:	6 Months to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation:
1. The subject is 6 months to 6 years of age
2. The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
3. The subject is scheduled for elective bilateral myringotomy with tube placement
4. The subject's parent/legally authorized guardian has given written informed consent to participate
  
  Exclusion Criteria:
Subjects will be excluded from study participation if any of the following exclusion criteria exists:
1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
2. The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
3. The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
4. The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
5. The subject has know central nervous system disease or neurological impairment
6. The subject is an ASA classification of 3 or greater (See Appendix 1)
7. The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
8. The subject refuses inhalation induction
9. The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654329

Locations

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010

Sponsors and Collaborators

Children's Research Institute

Hospira, Inc.

Investigators

Principal Investigator:

Julia C Finkel, MD

Children's Research Institute

More Information

No publications provided

Responsible Party:	Julia C. Finkel, MD, Children's National Medical Center
ClinicalTrials.gov Identifier:	NCT00654329 History of Changes
Other Study ID Numbers:	3641, Agreement # 10698
Study First Received:	April 3, 2008
Results First Received:	February 23, 2011
Last Updated:	March 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Research Institute:

Dexmedetomidine, transmucosal, myringotomy,

Additional relevant MeSH terms:

Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Fentanyl
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012