Clinical trial NCT00382083: Premedication to Reduce Discomfort With Screening Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Pain
Keywords: Mammogram
Pain
Discomfort
Breast
Pre-medication
Lead sponsor: Mountain States Tumor and Medical Research Institute
Sponsor class: OTHER
First posted: 2006-09-28
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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?

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 In an unpublished Master's thesis, this investigator found that women who expected discomfort \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

Eligibility 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.

Primary outcomes:
measure: Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram
measure: Satisfaction scores on a visual analog scale after mammogram
Secondary outcomes:
measure: Pre-mammogram anxiety scores on a visual anxiety scale at enrollment
measure: Pre-mammogram breast tenderness scores on a visual analog scale at enrollment
Other outcomes:
Locations:
city: Boise
country: United States
facility: St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center
state: Idaho
Study officials:
affiliation: Mountain States Oncology Group
name: Colleen K. Lambertz, MSN, FNP
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Mountain States Tumor Institute
name: Paul G Montgomery, MD
role: STUDY_CHAIR
affiliation: Mountain States Tumor Medical Research Institute
name: Theodore A Walters, MD
role: STUDY_DIRECTOR
References: