Using Dexamethasone After Uvulopalatopharyngoplasty

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT00584168
• Lead Sponsor: University of Oklahoma

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• Those patients who unable to take steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Patient will receive a placebo.
1	Dexamethasone	Patient will receive dexamethasone.

Primary Outcome Measures

Name	Time	Method
Quantifying patient treatment with a questionaire. Patient will rate their satisfaction with pain management.	Eleven days post-operative

Trial Locations

Locations (2)

Veterans Affairs Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States