Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

Nationwide Children's Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Otitis Media

Treatments: Drug: Fentanyl; Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01188551

IRB10-00377

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

dexmedetomidine w/ midazolam

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Drug: Midazolam

fentanyl w/ midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam

Drug: Fentanyl

dexmedetomidine w/o midazolam

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

fentanyl w/o midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl