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Using Dexamethasone After Uvulopalatopharyngoplasty
This study is currently recruiting participants.
Verified by University of Oklahoma, December 2008
First Received: December 20, 2007   Last Updated: December 10, 2008   History of Changes
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
Pain
Drug: Dexamethasone
Drug: Placebo
Phase I

MedlinePlus related topics: Surgery
Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate
U.S. FDA Resources
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

Further study details as provided by University of Oklahoma:

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

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
2: Placebo Comparator
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.
1: Experimental
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 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
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

Contacts
Contact: Dini Chissoe, BS 405-271-5504 geraldine-chissoe@ouhsc.edu

Locations
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
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 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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009