Premedication to Reduce Discomfort With Screening Mammography

NCT00382083 | Completed Phase 4

• 1 other identifier: MSTMRI - 001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 2.What is the relationship between perception of discomfort and overall satisfaction with the mammography experience?
3. 3.What is the relationship between the perception of discomfort and plans for future mammograms?
4. 4.What other factors are associated with the perception of discomfort and satisfaction?

Conditions

Breast Pain

Keywords

Mammogram; Pain; Discomfort; Breast; Pre-medication

Outcome Measures

Primary Outcomes (2)

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

• Satisfaction scores on a visual analog scale after mammogram

Secondary Outcomes (2)

• Pre-mammogram anxiety scores on a visual anxiety scale at enrollment

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

Interventions

1000 mg acetaminophen DRUG

800 mg ibuprofen DRUG

1 oz 4% lidocaine gel DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mountain States Tumor and Medical Research Institute: lead

Study Sites (1)

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

Boise, Idaho, 83712, United States

Location

MeSH Terms

Conditions

Mastodynia; Pain

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Colleen K. Lambertz, MSN, FNP

  Mountain States Oncology Group

  PRINCIPAL INVESTIGATOR

• Paul G Montgomery, MD

  St. Luke's Mountain States Tumor Institute

  STUDY CHAIR

• Theodore A Walters, MD

  Mountain States Tumor Medical Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: March 1, 2006
• Study Completion: June 1, 2006
• Last Updated: September 28, 2006

Record last verified: 2006-09

Locations

US (1)