Dexmedetomidine vs Fentanyl for BMT

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's National Research Institute; Children's Research Institute
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Dexmedetomidine; Fentanyl

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)