Breast PainPhase 4NCT00382083
Premedication to Reduce Discomfort With Screening Mammography
A Phase 4 study testing 1000 mg acetaminophen, 800 mg ibuprofen and 1 oz 4% lidocaine gel in people with Breast Pain, run by Mountain States Tumor and Medical Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Pain
- What is being tested?
- 1000 mg acetaminophen, 800 mg ibuprofen and 1 oz 4% lidocaine gel
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center
Boise, Idaho, 83712
About this study
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:
- What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine prior to screening mammography and the perception of discomfort during the procedure?
- What is the relationship between perception of discomfort and overall satisfaction with the mammography experience?
- What is the relationship between the perception of discomfort and plans for future mammograms?
- What other factors are associated with the perception of discomfort and satisfaction?
Read the 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.
- Conditions
- Breast Pain
- Being tested
- 1000 mg acetaminophen, 800 mg ibuprofen, 1 oz 4% lidocaine gel
- Keywords
- Mammogram, Pain, Discomfort, Breast, Pre-medication
- Medical subject headings
- Mastodynia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1000 mg acetaminophenDrug
800 mg ibuprofenDrug
1 oz 4% lidocaine gelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startMar 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Mountain States Tumor and Medical Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Colleen K. Lambertz, MSN, FNP, Principal investigator, Mountain States Oncology GroupPaul G Montgomery, MD, Study chair, St. Luke's Mountain States Tumor InstituteTheodore A Walters, MD, Study director, Mountain States Tumor Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382083
- Sponsor's protocol ID
- MSTMRI - 001
- Status last verified
- Sep 2006
- First submitted
- 26 Sep 2006
- Last updated
- 28 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication to Reduce Discomfort With Screening Mammography
- ClinicalTrials.gov ID
- NCT00382083
- Acronym / sponsor ID
- MSTMRI - 001
- Conditions
- Breast Pain
- Keywords
- Mammogram, Pain, Discomfort, Breast, Pre-medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mountain States Tumor and Medical Research InstituteUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Jun 2006
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine prior to screening mammography and the perception of discomfort during the procedure?
- What is the relationship between perception of discomfort and overall satisfaction with the mammography experience?
- What is the relationship between the perception of discomfort and plans for future mammograms?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1000 mg acetaminophen | Drug | – |
| 800 mg ibuprofen | Drug | – |
| 1 oz 4% lidocaine gel | Drug | – |
Primary outcome
Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram
Satisfaction scores on a visual analog scale after mammogram
2 secondary outcomes
Pre-mammogram anxiety scores on a visual anxiety scale at enrollment
Pre-mammogram breast tenderness scores on a visual analog scale at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2006.
Related trials for Breast Pain
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen K. Lambertz, MSN, FNP principal investigator
Mountain States Oncology Group
Paul G Montgomery, MD study chair
St. Luke's Mountain States Tumor Institute
Theodore A Walters, MD study director
Mountain States Tumor Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1000 mg acetaminophen, 800 mg ibuprofen and 1 oz 4% lidocaine gel in people with Breast Pain, run by Mountain States Tumor and Medical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2006.