Dexmedetomidine vs Fentanyl for BMT (DexBMT)

Children's National

Status and phase: Completed; Phase 4

Conditions: Otitis

Treatments: Drug: Fentanyl; Drug: Saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00654329

3641

Agreement # 10698

Details and patient eligibility

About

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

Enrollment: 101 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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101 participants in 4 patient groups, including a placebo group

Dexmedetomidine 1microgram/kilogram

Experimental group

Description:

Dexmedetomidine 1microgram/kilogram intranasal

Treatment:

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Dexmedetomidine 2 micrograms/kilogram

Experimental group

Description:

Dexmedetomidine 2 micrograms/kilogram intranasal

Treatment:

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Fentanyl 2 micrograms/kilogram

Active Comparator group

Description:

Fentanyl 2 micrograms/kilogram intranasal

Treatment:

Drug: Fentanyl

Normal saline placebo

Placebo Comparator group

Description:

Normal saline placebo intranasal

Treatment:

Drug: Saline