NCT00584168

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_1 pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

6.8 years

First QC Date

December 20, 2007

Last Update Submit

February 1, 2012

Conditions

Pain

Keywords

UPPPDexamethasoneUvulopalatopharyngoplastyPain ManagementIncreasing pain management in patients that have undergone UPPP surgery

Outcome Measures

Primary Outcomes (1)

  • Quantifying patient treatment with a questionaire. Patient will rate their satisfaction with pain management.

    Eleven days post-operative

Study Arms (2)

2

PLACEBO COMPARATOR

Patient will receive a placebo.

Drug: Placebo

1

EXPERIMENTAL

Patient will receive dexamethasone.

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

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
PlaceboDRUG

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Those patients who unable to take steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • John Houck, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 2, 2008

Study Start

March 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations

US(2)