Dexmedetomidine vs Fentanyl for BMT

Completed · Phase 4 · Has a placebo group

Conditions studied: Otitis

In brief

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

Key facts

Study ID

NCT00654329

Run by

Children's National Research Institute

People needed

101

Starts

2005-08-01

Expected to finish

2008-12-01

Last updated by the study team

2011-04-25

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible for participation:
• The subject is 6 months to 6 years of age
• The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
• The subject is scheduled for elective bilateral myringotomy with tube placement
• The subject's parent/legally authorized guardian has given written informed consent to participate

You may not qualify if…

• Subjects will be excluded from study participation if any of the following exclusion criteria exists:
• The subject has a history or a family (parent or sibling) history of malignant hyperthermia
• The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
• The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
• 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)
• The subject has know central nervous system disease or neurological impairment
• The subject is an ASA classification of 3 or greater (See Appendix 1)
• The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
• The subject refuses inhalation induction
• The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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