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Completed

NCT Number: NCT00382083

Premedication to Reduce Discomfort With Screening Mammography

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:

1. What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine prior to screening mammography and the perception of discomfort during the procedure? 2. What is the relationship between perception of discomfort and overall satisfaction with the mammography experience? 3. What is the relationship between the perception of discomfort and plans for future mammograms? 4. What other factors are associated with the perception of discomfort and satisfaction?

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Key information

Conditions

Breast Pain Mastodynia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center

Boise, Idaho, 83712, United States

About this study

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 In an unpublished Master's thesis, this investigator found that women who expected discomfort 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1000 mg acetaminophen

Drug

800 mg ibuprofen

Drug

1 oz 4% lidocaine gel

Drug

Primary outcomes

  1. Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram

  2. Satisfaction scores on a visual analog scale after mammogram

Secondary outcomes

  1. Pre-mammogram anxiety scores on a visual anxiety scale at enrollment

  2. Pre-mammogram breast tenderness scores on a visual analog scale at enrollment

Sponsors and collaborators

Lead sponsor

Mountain States Tumor and Medical Research Institute

Other

Registry information

Important dates

Study start
2006
Study completion
2006
First posted
Sep 28, 2006
Registry last updated
Sep 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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