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Clinical Trials/NCT00584168
NCT00584168CompletedPhase 1

Decreasing Morbidity After Uvulopalatopharyngoplasty With the Use of Dexamethasone - A Randomized Double Blinded Placebo Controlled Trial

University of Oklahoma2 sites in 1 country15 target enrollmentStarted: March 2005Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
15
Locations
2
Primary Endpoint
Quantifying patient treatment with a questionaire. Patient will rate their satisfaction with pain management.

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Those patients who unable to take steroids

Arms & Interventions

2

Placebo Comparator

Patient will receive a placebo.

Intervention: Placebo (Drug)

1

Experimental

Patient will receive dexamethasone.

Intervention: Dexamethasone (Drug)

Outcomes

Primary Outcomes

Quantifying patient treatment with a questionaire. Patient will rate their satisfaction with pain management.

Time Frame: Eleven days post-operative

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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