Chronic Otitis MediaPhase 2/3NCT01188551

Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

A Phase 2/3 study testing Dexmedetomidine, Fentanyl and Midazolam in people with Chronic Otitis Media, run by Nationwide Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Chronic Otitis Media
What is being tested?: Dexmedetomidine, Fentanyl and Midazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Apr 2012
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl

Conditions: Chronic Otitis Media
Being tested: Dexmedetomidine, Fentanyl, Midazolam
Keywords: myringotomy, pressure equalization tubes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Precedex
dexmedetomidine (1 µg/kg) will be administered intranasally
FentanylDrug
fentanyl (2 µg/kg) will be administered intranasally
MidazolamDrug
Also called Versed
Sedative given pre-op.

Study groups in NCT01188551
Study group	Role	What they receive
dexmedetomidine w/ midazolam	Experimental	Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR. Receives: Drug: Dexmedetomidine; Drug: 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. Receives: Drug: Fentanyl; Drug: Midazolam
dexmedetomidine w/o midazolam	Experimental	1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication. Receives: Drug: Dexmedetomidine
fentanyl w/o midazolam	Active comparator	1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication. Receives: Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 30 mins. post-op

Secondary outcomes (1)

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.
Measured: 30 mins. post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Apr 2012

First posted25 Aug 2010 (estimated)
Study startJan 2011
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Otitis MediaStudies of the same condition, open and under way.
More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01188551
Sponsor's protocol ID: IRB10-00377
Status last verified: Feb 2014
First submitted: 24 Aug 2010
Last updated: 1 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 17273114
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.
PubMed 17646493

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl
ClinicalTrials.gov ID: NCT01188551
Acronym / sponsor ID: IRB10-00377
Conditions: Chronic Otitis Media
Keywords: myringotomy, pressure equalization tubes
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Nationwide Children's HospitalUniversity, hospital or other
Study start: Jan 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 25 Aug 2010 (estimated)
Results: Posted 1 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
dexmedetomidine w/ midazolam	Experimental	Drug: Dexmedetomidine, Drug: MidazolamMidazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.
fentanyl w/ midazolam	Active comparator	Drug: Fentanyl, Drug: MidazolamMidazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.
dexmedetomidine w/o midazolam	Experimental	Drug: Dexmedetomidine1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication.
fentanyl w/o midazolam	Active comparator	Drug: Fentanyl1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmedetomidineAlso: Precedexdexmedetomidine (1 µg/kg) will be administered intranasally	Drug	dexmedetomidine w/ midazolam, dexmedetomidine w/o midazolam
Fentanylfentanyl (2 µg/kg) will be administered intranasally	Drug	fentanyl w/ midazolam, fentanyl w/o midazolam
MidazolamAlso: VersedSedative given pre-op.	Drug	dexmedetomidine w/ midazolam, fentanyl w/ midazolam

Primary outcome

FLACC Behavioral Pain Assessment Scale Scores
Time frame: 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

1 secondary outcome

Recovery From General Anesthesia
Time frame: 30 mins. post-op

Results and safety

Results posted to the registry on 1 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexmedetomidine w/ Midazolam	25	24
Fentanyl w/ Midazolam	25	25
Dexmedetomidine w/o Midazolam	25	25
Fentanyl w/o Midazolam	25	25

Primary outcome: FLACC Behavioral Pain Assessment Scale Scores

Time frame: 30 mins. post-op. Mean (Standard Deviation). Unit: units on a scale

Measure	Dexmedetomidine w/ Midazolam n = 24	Fentanyl w/ Midazolam n = 25	Dexmedetomidine w/o Midazolam n = 25	Fentanyl w/o Midazolam n = 25
Value	5 (4.19)	3 (3.60)	1 (2.20)	2 (2.92)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexmedetomidine w/ Midazolam	0 of 25 (0%)	0 of 25 (0%)	Not reported
Fentanyl w/ Midazolam	0 of 25 (0%)	0 of 25 (0%)	Not reported
Dexmedetomidine w/o Midazolam	0 of 25 (0%)	0 of 25 (0%)	Not reported
Fentanyl w/o Midazolam	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17273114Tobias 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.
Background: PubMed 17646493Yuen 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dexmedetomidine, Fentanyl and Midazolam in people with Chronic Otitis Media, run by Nationwide Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FLACC Behavioral Pain Assessment Scale Scores (time frame: 30 mins. post-op). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01188551, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.