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Sponsored by: |
University of Oklahoma |
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Information provided by: | University of Oklahoma |
ClinicalTrials.gov Identifier: | NCT00584168 |
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 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | John Houck, MD | University of Oklahoma |
Responsible Party: | University of Oklahoma Health Sciences Center ( John Houck, MD ) |
Study ID Numbers: | Dexamethasone, UPPP - Houck, UPPP Study, IRB # 12098 |
Study First Received: | December 20, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00584168 History of Changes |
Health Authority: | United States: Institutional Review Board |
UPPP Dexamethasone Uvulopalatopharyngoplasty Pain Management Increasing pain management in patients that have undergone UPPP surgery |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Pain Peripheral Nervous System Agents Hormones Glucocorticoids Dexamethasone acetate |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents Dexamethasone acetate |