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Using Dexamethasone After Uvulopalatopharyngoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584168
First received: December 20, 2007
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
 Drug: Dexamethasone
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Decreasing Morbidity After Uvulopalatopharyngoplasty With the Use of Dexamethasone - A Randomized Double Blinded Placebo Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Quantifying patient treatment with a questionaire. Patient will rate their satisfaction with pain management. [ Time Frame: Eleven days post-operative ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Patient will receive a placebo.
 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.
Experimental: 1
Patient will receive dexamethasone.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Those patients who unable to take steroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584168

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: John Houck, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00584168     History of Changes
Other Study ID Numbers: Dexamethasone, UPPP - Houck, UPPP Study, IRB # 12098
Study First Received: December 20, 2007
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
UPPP
Dexamethasone
Uvulopalatopharyngoplasty
Pain Management
Increasing pain management in patients that have undergone UPPP surgery

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013