Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

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.

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Detailed Description

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Conditions

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Chronic Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexmedetomidine w/ midazolam

Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine (1 µg/kg) will be administered intranasally

Midazolam

Intervention Type DRUG

Sedative given pre-op.

fentanyl w/ midazolam

Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

fentanyl (2 µg/kg) will be administered intranasally

Midazolam

Intervention Type DRUG

Sedative given pre-op.

dexmedetomidine w/o midazolam

1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine (1 µg/kg) will be administered intranasally

fentanyl w/o midazolam

1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

fentanyl (2 µg/kg) will be administered intranasally

Interventions

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Dexmedetomidine

dexmedetomidine (1 µg/kg) will be administered intranasally

Intervention Type DRUG

Fentanyl

fentanyl (2 µg/kg) will be administered intranasally

Intervention Type DRUG

Midazolam

Sedative given pre-op.

Intervention Type DRUG

Other Intervention Names

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Precedex Versed

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No