Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

Study Overview
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Brief Summary
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This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.

Official Title
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Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl

Conditions
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Chronic Otitis Media

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease) patients scheduled for placement of bilateral myringotomy tubes Exclusion Criteria: history of allergy to either dexmedetomidine or fentanyl concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine w/ midazolam<br>Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR. | Drug: Dexmedetomidine<br>* dexmedetomidine (1 µg/kg) will be administered intranasally<br>* Other names: Precedex;Drug: Midazolam<br>* Sedative given pre-op.<br>* Other names: Versed;|
| Active Comparator: fentanyl w/ midazolam<br>Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR. | Drug: Fentanyl<br>* fentanyl (2 µg/kg) will be administered intranasally<br>Drug: Midazolam<br>* Sedative given pre-op.<br>* Other names: Versed;|
| Experimental: dexmedetomidine w/o midazolam<br>1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication. | Drug: Dexmedetomidine<br>* dexmedetomidine (1 µg/kg) will be administered intranasally<br>* Other names: Precedex;|
| Active Comparator: fentanyl w/o midazolam<br>1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication. | Drug: Fentanyl<br>* fentanyl (2 µg/kg) will be administered intranasally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC Behavioral Pain Assessment Scale Scores | FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both | 30 mins. post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery From General Anesthesia | Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge. | 30 mins. post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myringotomy, pressure equalization tubes