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| Sponsored by: |
University of Oklahoma |
| Information provided by: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00584168 |
Purpose
This study looks at lessening the pain after a Uvulopalatopharyngoplasty (UPPP) surgery by using Dexamethasone (a corticosteroid).
| Condition | Intervention | Phase |
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Pain |
Drug: Dexamethasone Drug: Placebo |
Phase I |
| Drug Information available for: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Decreasing Morbidity After Uvulopalatopharyngoplasty With the Use of Dexamethasone - A Randomized Double Blinded Placebo Controlled Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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2: Placebo Comparator
Patient will receive a placebo.
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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.
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1: Experimental
Patient will receive dexamethasone.
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Drug: 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.
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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 questionaire. 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 satification with pain management.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dini Chissoe, BS | 405-271-5504 | geraldine-chissoe@ouhsc.edu |
| United States, Oklahoma | |||||
| University of Oklahoma Health Sciences Center | Recruiting | ||||
| Oklahoma City, Oklahoma, United States, 73104 | |||||
| Veterans Affairs Medical Center | Recruiting | ||||
| Oklahoma City, Oklahoma, United States, 73104 | |||||
| University of Oklahoma |
| Principal Investigator: | John Houck, MD | University of Oklahoma |
More Information
| Responsible Party: | University of Oklahoma Health Sciences Center ( John Houck, MD ) |
| Study ID Numbers: | Dexamethasone, UPPP - Houck, UPPP Study, IRB # 12098 |
| First Received: | December 20, 2007 |
| Last Updated: | June 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00584168 |
| Health Authority: | United States: Institutional Review Board |
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