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Premedication to Reduce Discomfort With Screening Mammography

NCT ID: NCT00382083

Last Updated: 2006-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-06-30

Brief Summary

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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

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 In an unpublished Master's thesis, this investigator found that women who expected discomfort \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

Conditions

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Breast Pain

Keywords

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Mammogram Pain Discomfort Breast Pre-medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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1000 mg acetaminophen

Intervention Type DRUG

800 mg ibuprofen

Intervention Type DRUG

1 oz 4% lidocaine gel

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mountain States Tumor and Medical Research Institute

OTHER

Sponsor Role lead

Principal Investigators

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Colleen K. Lambertz, MSN, FNP

Role: PRINCIPAL_INVESTIGATOR

Mountain States Oncology Group

Paul G Montgomery, MD

Role: STUDY_CHAIR

St. Luke's Mountain States Tumor Institute

Theodore A Walters, MD

Role: STUDY_DIRECTOR

Mountain States Tumor Medical Research Institute

Locations

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

Boise, Idaho, United States

Site Status

Countries

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United States

Other Identifiers

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MSTMRI - 001

Identifier Type: -

Identifier Source: org_study_id