Women's Mammography Study To Improve Comfort During Mammography

Kenneth A. Kist,

Status: Terminated

Conditions: Pain

Treatments: Drug: Ibuprofen; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01716052

CTRC 11-45

HSC20120142H (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.

Full description

This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must have signed the informed consent.
• Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain

Exclusion criteria

• May not have taken ibuprofen or other pain medication within the last 12 hours.
• Must not have a contraindication for taking ibuprofen e.g:
• No history of allergic reactions to ibuprofen or aspirin
• No recent history with the last year of bleeding from GI tract
• Not pregnant or suspected of being pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Ibuprofen

Active Comparator group

Description:

Pfizer 200 mg caplets (Advil)

Treatment:

Drug: Ibuprofen

Placebo

Placebo Comparator group

Description:

Lactulose

Treatment:

Drug: placebo