Premedication to Reduce Discomfort With Screening Mammography

Breast Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382083
• Other study ID #: MSTMRI - 001
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2006
• Last updated: September 27, 2006
• Start date: March 2006
• Est. completion date: June 2006

Study information

• Verified date: September 2006
• Source: Mountain States Tumor and Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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?

Description:

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 In an unpublished Master’s thesis, this investigator found that women who expected discomfort 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Pain

Intervention

Drug:
• 1000 mg acetaminophen

• 800 mg ibuprofen

• 1 oz 4% lidocaine gel

Locations

Country	Name	City	State
United States	St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center	Boise	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Mountain States Tumor and Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram
Primary	Satisfaction scores on a visual analog scale after mammogram
Secondary	Pre-mammogram anxiety scores on a visual anxiety scale at enrollment
Secondary	Pre-mammogram breast tenderness scores on a visual analog scale at enrollment