search
Back to results

Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

Primary Purpose

Chronic Otitis Media

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Fentanyl
Midazolam
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Otitis Media focused on measuring myringotomy, pressure equalization tubes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

dexmedetomidine w/ midazolam

fentanyl w/ midazolam

dexmedetomidine w/o midazolam

fentanyl w/o midazolam

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 24, 2010
Last Updated
February 17, 2014
Sponsor
Nationwide Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01188551
Brief Title
Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement
Official Title
Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Otitis Media
Keywords
myringotomy, pressure equalization tubes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine w/ midazolam
Arm Type
Experimental
Arm Description
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.
Arm Title
fentanyl w/ midazolam
Arm Type
Active Comparator
Arm Description
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.
Arm Title
dexmedetomidine w/o midazolam
Arm Type
Experimental
Arm Description
1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication.
Arm Title
fentanyl w/o midazolam
Arm Type
Active Comparator
Arm Description
1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
dexmedetomidine (1 µg/kg) will be administered intranasally
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
fentanyl (2 µg/kg) will be administered intranasally
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
Sedative given pre-op.
Primary Outcome Measure Information:
Title
FLACC Behavioral Pain Assessment Scale Scores
Description
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
Time Frame
30 mins. post-op
Secondary Outcome Measure Information:
Title
Recovery From General Anesthesia
Description
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.
Time Frame
30 mins. post-op

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17273114
Citation
Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric anesthesiology. Pediatr Crit Care Med. 2007 Mar;8(2):115-31. doi: 10.1097/01.PCC.0000257100.31779.41.
Results Reference
background
PubMed Identifier
17646493
Citation
Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
Results Reference
background

Learn more about this trial

Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

We'll reach out to this number within 24 hrs