Trial | NCT00382083  Report issue

Title

Premedication to Reduce Discomfort With Screening Mammography

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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?
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 In an unpublished Master's thesis, this investigator found that women who expected discomfort 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 Started
Mar 31
2006
Study Completion
Jun 30
2006
Last Update
Sep 28
2006
Estimate

Drug 1000 mg acetaminophen

Drug 800 mg ibuprofen

Drug 1 oz 4% lidocaine gel

Criteria 

Inclusion Criteria:

Women scheduled for age-appropriate screening mammography at St. Luke's Breast Cancer Detection Center
Expect discomfort of 40 or greater on a scale of 0-100
Willing to arrive 1 hour early for appointment to enroll in study

Exclusion Criteria:

Women who:

expect discomfort from their mammogram to be < 40 on a scale of 0-100
cannot understand or read English or who are unable to complete the consent process or questionnaire for reasons such as hearing impairment or other physical or mental disabilities
have a sensitivity or allergy to acetaminophen, ibuprofen, or lidocaine
have significant liver or kidney dysfunction
are breast-feeding
cannot arrive a minimum of 60 minutes earlier than their appointment time
have taken any pain relief medications within 24 hours of their mammogram appointment, including over-the-counter medications.
No Results Posted