NCT01188551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

August 24, 2010

Results QC Date

June 26, 2013

Last Update Submit

February 17, 2014

Conditions

Chronic Otitis Media

Keywords

myringotomypressure equalization tubes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Recovery From General Anesthesia

    30 mins. post-op

Study Arms (4)

dexmedetomidine w/ midazolam

EXPERIMENTAL

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

Drug: DexmedetomidineDrug: Midazolam

fentanyl w/ midazolam

ACTIVE COMPARATOR

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

Drug: FentanylDrug: Midazolam

dexmedetomidine w/o midazolam

EXPERIMENTAL

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

Drug: Dexmedetomidine

fentanyl w/o midazolam

ACTIVE COMPARATOR

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

Drug: Fentanyl

Interventions

DexmedetomidineDRUG

dexmedetomidine (1 µg/kg) will be administered intranasally

Also known as: Precedex
dexmedetomidine w/ midazolamdexmedetomidine w/o midazolam
FentanylDRUG

fentanyl (2 µg/kg) will be administered intranasally

fentanyl w/ midazolamfentanyl w/o midazolam
MidazolamDRUG

Sedative given pre-op.

Also known as: Versed
dexmedetomidine w/ midazolamfentanyl w/ midazolam

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

  • 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.

    PMID: 17273114BACKGROUND

  • 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.

    PMID: 17646493BACKGROUND

MeSH Terms

Interventions

DexmedetomidineFentanylMidazolam

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidinesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Joseph D. Tobias, MD
Organization
Nationwide Children's Hospital
Joseph.Tobias@nationwidechildrens.org
614-722-4200

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 25, 2010

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 1, 2014

Results First Posted

April 1, 2014

Record last verified: 2014-02

Locations

US(1)