Effective strategy to cope the pain and discomfort among women undergoing mammography - A randomized controlled trial

OBJECTIVES: To evaluate the role of paracetamol in reducing pain and discomfort during the mammography procedure. METHODS: This randomized double-blind placebo-controlled trial was conducted at DIR, Ojha and LEJ Campus of DUHS from November 2019 to May 2021. All females aged above 40 years undergoing first time mammogram (screening or diagnostic) were enrolled. Of 639 included participants, 321 were included in paracetamol and 318 in placebo group. Patients in both the groups took medication orally which was customized by the Dow Pharmacy. The degree of pain felt during the mammography procedure was the outcome variable that was measured using Visual Analogue Scale. RESULTS: The overall pain was found in 506 (79.19%) women. Pain was significantly higher in women who were in placebo group as compared to patients who were in paracetamol group, i.e., 280 (55.3%) and 226 (44.7%) (p-value <0.001). After adjustment of other covariates, the odds of pain was 3.64 times significantly higher in women who were in placebo group than that of women in paracetamol group (OR 3.64, 95% CI 2.31-5.74). Moreover, >25kg/m(2) BMI was 2.84 times, 22.6-25 kg/m(2) BMI was 2.29 times, nulligravida was 3.56 times, menopausal status was 2.23 times, pre-menopausal status was 4.51 times, and family history of breast cancer was 2.33 times significantly more likely to have pain. No post-trial complications were observed in both the groups. CONCLUSION: The use of paracetamol prior to the mammography procedure was found to be an effective intervention to reduce the pain among women. Clinical Trials: Identifier: NCT04381104.