Using Dexamethasone After Uvulopalatopharyngoplasty

NCT ID: NCT00584168

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2011-12-31

Brief Summary

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This study looks at lessening the pain after a Uvulopalatopharyngoplasty (UPPP) surgery by using Dexamethasone (a corticosteroid).

Detailed Description

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The study was designed because patients have a lot of pain after they have a UPPP. Certain drugs called steroids may lessen the pain associated from this surgery. This study uses Dexamethasone (a corticosteroid), to see if it will help reduce pain, decrease the amount of time until the patient can begin to eat or return to normal activity, or increase their satisfaction with pain management. In this study the patients will be randomized (computer chosen) to receive either the study drug (dexamethasone), or a placebo. The patient will start the day before surgery with a single pill. They will then receive the dexamethasone or a placebo twice daily for the next four days and then once daily for the next two days for a total of seven days. Afterward, they will be asked to complete a questionnaire. The five questions ask patients to access the amount of pain they have, how much of their normal diet or activity they have returned to, and how much pain medication they have taken. At the next follow-up visit they will be asked to complete another questionaire (9 questions) about the patient's satisfaction with pain management.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Patient will receive a placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.

1

Patient will receive dexamethasone.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.

Interventions

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Dexamethasone

They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.

Intervention Type DRUG

Placebo

They will take a pill the day before surgery, twice daily for the next four days and then once daily for the next two days for a total of seven days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Candidates scheduled for UPPP surgery.
* Able to take steroids

Exclusion Criteria

* Those patients who unable to take steroids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Houck, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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UPPP Study, IRB # 12098

Identifier Type: OTHER

Identifier Source: secondary_id

Dexamethasone, UPPP - Houck

Identifier Type: -

Identifier Source: org_study_id

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