Dexmedetomidine vs Fentanyl for BMT (DexBMT)
Otitis
About this trial
This is an interventional treatment trial for Otitis focused on measuring Dexmedetomidine, transmucosal, myringotomy,
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Sites / Locations
- Children's National Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
Dexmedetomidine 1microgram/kilogram
Dexmedetomidine 2 micrograms/kilogram
Fentanyl 2 micrograms/kilogram
Normal saline placebo
Dexmedetomidine 1microgram/kilogram intranasal
Dexmedetomidine 2 micrograms/kilogram intranasal
Fentanyl 2 micrograms/kilogram intranasal
Normal saline placebo intranasal