Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

Phase 2

Completed

• Conditions: Chronic Otitis Media
• Interventions: Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Midazolam

• Registration Number: NCT01188551
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Study Start: 2011-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-06-26
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-17
• Last Update Submitted: 2014-02-17
• Results First Posted: 2014-04-01
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fentanyl w/ midazolam	Midazolam	Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.
dexmedetomidine w/o midazolam	Dexmedetomidine	1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication.
dexmedetomidine w/ midazolam	Dexmedetomidine	Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.
dexmedetomidine w/ midazolam	Midazolam	Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.
fentanyl w/ midazolam	Fentanyl	Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.
fentanyl w/o midazolam	Fentanyl	1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.

Primary Outcome Measures

Name	Time	Method
FLACC Behavioral Pain Assessment Scale Scores	30 mins. post-op	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

Secondary Outcome Measures

Name	Time	Method
Recovery From General Anesthesia	30 mins. post-op	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States