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This study will explore the effect of pre-medication with acetaminophen, ibuprofen, and topical lidocaine gel (Topicaine) on the perception of discomfort and overall satisfaction with the mammography experience.
The research questions are:
Breast cancer is prevalent, deadly, costly, and has low cure rates unless detected in its early stages. Mammography is the key component to early detection, yet it remains underutilized due to cost, access, and factors such as fear of pain.
Multiple studies have shown that most women find mammography uncomfortable, even painful. Yet, little research has been done to find methods to reduce mammography-related discomfort. In an unpublished Master's thesis, this investigator found that women who expected discomfort > 40 on a visual analog scale (VAS) who were pre-medicated with 1000 mg of acetaminophen reported lower discomfort scores than those pre-medicated with placebo, but the sample size was too small to reach statistical significance. Further study on the effects of pre-medication is needed.
Pain should not be associated with a potentially lifesaving procedure. A more comfortable and positive experience with mammography may increase the number of women who participate in regular mammography screening, and, thereby, increase early detection and reduce the mortality rate, costs, and emotional trauma associated with breast cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1000 mg acetaminophen | Drug | |||
| 800 mg ibuprofen | Drug | |||
| 1 oz 4% lidocaine gel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram | ||
| Satisfaction scores on a visual analog scale after mammogram |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-mammogram anxiety scores on a visual anxiety scale at enrollment | ||
| Pre-mammogram breast tenderness scores on a visual analog scale at enrollment |
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Inclusion Criteria:
Exclusion Criteria:
Women who:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen K. Lambertz, MSN, FNP | Mountain States Oncology Group | Principal Investigator |
| Paul G Montgomery, MD | St. Luke's Mountain States Tumor Institute | Study Chair |
| Theodore A Walters, MD | Mountain States Tumor Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center | Boise | Idaho | 83712 | United States |
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| ID | Term |
|---|---|
| D059373 | Mastodynia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |