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Status:

COMPLETED

Dexmedetomidine vs Fentanyl for BMT

Lead Sponsor:

Children's National Research Institute

Collaborating Sponsors:

Hospira, now a wholly owned subsidiary of Pfizer

Conditions:

Otitis

Eligibility:

All Genders

6-6 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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)

Key Trial Info

Start Date :

August 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT00654329

Start Date

August 1 2005

End Date

December 1 2008

Last Update

April 25 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010