Dexmedetomidine vs Fentanyl for BMT

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

Official Title
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Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)

Conditions
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Otitis

Intervention / Treatment
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* Drug: Saline
* Drug: Fentanyl
* Drug: Dexmedetomidine
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine 1microgram/kilogram<br>Dexmedetomidine 1microgram/kilogram intranasal | Drug: Dexmedetomidine<br>* Dexmedetomidine, transmucosal, 1 microgram/kilogram<br>* Other names: Precedex;|
| Experimental: Dexmedetomidine 2 micrograms/kilogram<br>Dexmedetomidine 2 micrograms/kilogram intranasal | Drug: Dexmedetomidine<br>* Dexmedetomidine, 2 microgram/kilogram, transmucosal route<br>* Other names: Precedex;|
| Active Comparator: Fentanyl 2 micrograms/kilogram<br>Fentanyl 2 micrograms/kilogram intranasal | Drug: Fentanyl<br>* Fentanyl, nasal transmucosal, 2 micrograms/kilogram<br>* Other names: Actiq, Fentora;|
| Placebo Comparator: Normal saline placebo<br>Normal saline placebo intranasal | Drug: Saline<br>* Normal saline, given intranasally<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pain | Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU) | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in PACU | Total time from PACU entry until discharge | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, transmucosal, myringotomy,