Double-blind placebo-controlled randomized clinical trial on the use of paracetamol for performing mammography

Ruffo Freitas-Junior, Edesio Martins, Cristiane Metran-Nascente, Angela Assis Carvalho, Marilceia Ferreira da Silva, Leonardo Ribeiro Soares, Carlos Alberto Ximenes, Ruffo Freitas-Junior, Edesio Martins, Cristiane Metran-Nascente, Angela Assis Carvalho, Marilceia Ferreira da Silva, Leonardo Ribeiro Soares, Carlos Alberto Ximenes

Abstract

Background: This study was conducted within the Goias Mastology Research Network. To verify the possibility of diminishing pain, and discomfort during the mammography using analgesic administration.

Methods: Randomized, double-blinded, placebo controlled trial, testing paracetamol to diminish the pain, and discomfort during mammography. Three hundred patients who came for screening mammography were randomized for this study. A questionnaire with 2 parts was used: the first had questions that concerned the patient identification, and factors related to the pain during mammography; and the second asked about the scale of discomfort (no discomfort; uncomfortable; very uncomfortable; intolerable), and the pain (analogical linear scale) during the mammography. Each patient received 1000 mg of paracetamol, or placebo. Afterwards each patient filled out the second part of the questionnaire. Six patients were excluded from the analysis; this resulted in 149 in the paracetamol group, and 145 in the placebo group.

Results: The 2 groups were homogenous concerning the mean of the ages, weight, height, and breast size. The mean of the pain was 3.5 in the paracetamol, and 2.8 in the placebo group (P = .12). There were fewer women experiencing mild pain in the paracetamol group when compared with those in placebo group (relative risk [RR] 0.76, confidence interval [CI] 95% 0.52-0.98). There was no significant difference between the 2 groups, according to the degrees of discomfort (P = .69).

Conclusion: The use of paracetamol can reduces the mild pain for women undergoing mammography.

Conflict of interest statement

The authors report no conflicts of interest

Figures

Figure 1
Figure 1
Study design, and distribution of patients into the groups. VAS = visual analog pain scale.
Figure 2
Figure 2
Forest plot for subgroup analysis.

References

    1. Coldman A, Phillips N, Wilson C, et al. Pan-Canadian study of mammography screening and mortality from breast cancer. J Natl Cancer Inst 2014;106:
    1. Tabár L, Yen AM, Wu WY, et al. Insights from the breast cancer screening trials: how screening affects the natural history of breast cancer and implications for evaluating service screening programs. Breast J 2015;21:13–20.
    1. Pocobelli G, Weiss NS. Breast cancer mortality in relation to receipt of screening mammography: a case-control study in Saskatchewan, Canada. Cancer Causes Control 2015;26:231–7.
    1. Scaf-Klomp W, Van Sonderen E, Van Den Heuval W. Compliance after 17 years of breast cancer screening: factors associated with re attendance for periodic breast screening. Eur J Public Health 1997;7:182–7.
    1. Saunders RS, Jr, Samei E. The effect of breast compression on mass conspicuity in digital mammography. Med Phys 2008;35:4464–73.
    1. Hauge IH, Pedersen K, Sanderud A, et al. Patient doses from screen-film and full-field digital mammography in a population-based screening programme. Radiat Prot Dosimetry 2012;148:65–73.
    1. Freitas Júnior R, Fiori WF, Ramos FJF, et al. Discomfort and pain during mammography. Rev Assoc Med Bras 2006;52:333–6.
    1. Zavotsky KE, Banavage A, James P, et al. The effects of music on pain and anxiety during screening mammography. Clin J Oncol Nurs 2014;18:E45–9.
    1. Davey B. Pain during mammography: possible risk factors and ways to alleviate pain. Radiography (Lond) 2007;13:229–34.
    1. Kataria K, Dhar A, Srivastava A, et al. A systematic review of current understanding and management of mastalgia. Indian J Surg 2014;76:217–22.
    1. Raffa RB, Pergolizzi JV, Jr, Taylor R, Jr, et al. Acetaminophen (paracetamol) oral absorption and clinical influences. Pain Pract 2014;14:668–77.
    1. de Groot JE, Broeders MJ, Branderhorst W, et al. A novel approach to mammographic breast compression: Improved standardization and reduced discomfort by controlling pressure instead of force. Med Phys 2013;40:081901.
    1. Keemers-Gels ME, Groenendijk RP, van den Heuvel JH, et al. Pain experienced by women attending breast cancer screening. Breast Cancer Res Treat 2000;60:235–40.
    1. Ryerson AB, Miller J, Eheman CR. Reported breast symptoms in the national breast and cervical cancer early detection program. Cancer Causes Control 2015;26:733–40.
    1. Cockburn J, Cawson J, Hill D, et al. An analysis of reported discomfort caused by mammographic X-ray amongst attenders at an Australian pilot breast screening program. Australas Radiol 1992;36:115–9.
    1. Elwood M, McNoe B, Smith T, et al. Once is enough--why some women do not continue to participate in a breast cancer screening programme. N Z Med J 1998;111:180–3.
    1. de Groot JE, Branderhorst W, Grimbergen CA, et al. Towards personalized compression in mammography: a comparison study between pressure- and force-standardization. Eur J Radiol 2015;84:384–91.
    1. Drossaert CH, Boer H, Seydel ER. Monitoring women's experiences during three rounds of breast cancer screening: results from a longitudinal study. J Med Screen 2002;9:168–75.
    1. Kersten P, White PJ, Tennant A. Is the pain visual analogue scale linear and responsive to change? An exploration using Rasch analysis. PLoS One 2014;9:e99485.doi: 10.1371/journal.pone.0099485.
    1. Lambertz CK, Johnson CJ, Montgomery PG, et al. Premedication to reduce discomfort during screening mammography. Radiology 2008;248:765–72.
    1. Miller D, Livingstone V, Herbison P. Interventions for relieving the pain and discomfort of screening mammography. Cochrane Database Syst Rev 2008;CD002942.doi: 10.1002/14651858.CD002942.pub2.
    1. Zhang J, Silber JI, Mazurowski MA. Modeling false positive error making patterns in radiology trainees for improved mammography education. J Biomed Inform 2015;54:50–7. doi: 10.1016/j.jbi.2015.01.007.
    1. Broeders MJ, Ten Voorde M, Veldkamp WJ, et al. Comparison of a flexible versus a rigid breast compression paddle: pain experience, projected breast area, radiation dose and technical image quality. Eur Radiol 2015;25:821–9.
    1. Fayanju OM, Kraenzle S, Drake BF, et al. Perceived barriers to mammography among underserved women in a breast health center outreach program. Am J Surg 2014;208:425–34.

Source: PubMed

3
Se inscrever