Premedication to Reduce Discomfort With Screening Mammography
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|ClinicalTrials.gov Identifier: NCT00382083|
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : September 28, 2006
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:
- What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine prior to screening mammography and the perception of discomfort during the procedure?
- What is the relationship between perception of discomfort and overall satisfaction with the mammography experience?
- What is the relationship between the perception of discomfort and plans for future mammograms?
- What other factors are associated with the perception of discomfort and satisfaction?
|Condition or disease||Intervention/treatment||Phase|
|Breast Pain||Drug: 1000 mg acetaminophen Drug: 800 mg ibuprofen Drug: 1 oz 4% lidocaine gel||Phase 4|
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 In an unpublished Master’s thesis, this investigator found that women who expected discomfort 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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||March 2006|
|Estimated Study Completion Date :||June 2006|
- Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram
- Satisfaction scores on a visual analog scale after mammogram
- Pre-mammogram anxiety scores on a visual anxiety scale at enrollment
- Pre-mammogram breast tenderness scores on a visual analog scale at enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382083
|United States, Idaho|
|St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center|
|Boise, Idaho, United States, 83712|
|Principal Investigator:||Colleen K. Lambertz, MSN, FNP||Mountain States Oncology Group|
|Study Chair:||Paul G Montgomery, MD||St. Luke's Mountain States Tumor Institute|
|Study Director:||Theodore A Walters, MD||Mountain States Tumor Medical Research Institute|