Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00382083
Other study ID # MSTMRI - 001
Secondary ID
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 In an unpublished Master’s thesis, this investigator found that women who expected discomfort 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
Est. primary completion date
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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02893384 - Local Anesthetic for Total Mastectomy Surgery Phase 4
Completed NCT03877146 - Calming Alternatives Learned During MRI-Guided Breast Biopsy N/A
Not yet recruiting NCT03936842 - Evaluation of an Educational Intervention for Women With Breast Pain N/A
Terminated NCT00276419 - Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin Phase 2/Phase 3
Completed NCT05456594 - Comparing Sports Bra Design in Full Busted Women N/A
Completed NCT05185752 - Comparative Analysis of Three Locoregional Anesthesia Methods in Breast Tumour Pathology Surgery N/A
Terminated NCT03877094 - e-Nature VR: Evaluation of the Impact of Virtual Reality During Breast Biopsy N/A
Completed NCT02093338 - L.Fermentum CECT5716 in Treatment of Breast Pain N/A
Recruiting NCT04967352 - Predicting Chronic Pain Following Breast Surgery
Recruiting NCT03708302 - Serratus and Parasternal Infrapectoral Block for Breast Surgery. N/A
Recruiting NCT03700177 - Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block Phase 4
Recruiting NCT04238377 - Post Mastectomy Pain Syndrome After Preoperative Stellate Ganglion Block for Breast Cancer Surgeries N/A
Completed NCT06026176 - Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS
Completed NCT04586751 - The Impact of Pecs Blocks on Postmastectomy Pain Syndrome N/A
Completed NCT03392675 - Breastfeeding Self-Management for Nipple and Breast Pain N/A
Completed NCT00534846 - The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia Phase 3
Completed NCT00275574 - Acupuncture for Non-cyclical Breast Pain N/A