Pain
Conditions
Keywords
Mammogram, Ibuprofen, Pain management
Brief summary
The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.
Detailed description
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.
Interventions
DRUGplacebo
Lactulose
DRUGIbuprofen
Sponsors
Kenneth A. Kist,
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Must have signed the informed consent. * Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain
Exclusion criteria
* May not have taken ibuprofen or other pain medication within the last 12 hours. * Must not have a contraindication for taking ibuprofen e.g: * No history of allergic reactions to ibuprofen or aspirin * No recent history with the last year of bleeding from GI tract * Not pregnant or suspected of being pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Discomfort of Mammography | 3 years | The primary outcome measure will be the response to questions on a questionnaire. |
Countries
United States
Participant flow
Recruitment details
When the woman signs in at the breast imaging clinic desk (on the 5th floor of the Zeller Building at the CTRC), she will be asked if she would speak with the study nurse about this study.
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Pfizer 200 mg caplets (Advil)
Ibuprofen | 1 |
| Placebo Lactulose
placebo: Lactulose | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal of funding | 1 | 1 |
Baseline characteristics
| Characteristic | Ibuprofen | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Measure of Discomfort of Mammography
The primary outcome measure will be the response to questions on a questionnaire.
Time frame: 3 years
Population: No data was collected or analyzed for the outcome measure because the study was terminated.