Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy (DexT&A)
Tonsillitis
About this trial
This is an interventional treatment trial for Tonsillitis focused on measuring Dexmedetomidine,, fentanyl,, tonsillectomy, and adenoidectomy,
Eligibility Criteria
Inclusion Criteria:
All of the following criteria must be met for the potential subject to be eligible for participation:
- The subject is 2 to 12 years of age
- The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
- The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
- The subject will be hospitalized overnight after surgery
The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.
Exclusion Criteria:
The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:
- 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
- The subject is a pregnant or lactating female (if post-menarcheal, a negative pregnancy test must be confirmed prior to the planned surgery time (in AMSAC) consistent with current standard of care.
- The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where hypotension is to be avoided).
Sites / Locations
- Children's National Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Experimental
Experimental
Fentanyl 1
Fentanyl 2
Dex 3
Dex 4
Fentanyl 1 micrograms (mcg)/kilogram (kg)
Fentanyl 2 micrograms (mcg)/kilogram (kg)
Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)
Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)