UNASSIGNED: 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.
UNASSIGNED: 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/m2 BMI was 2.84 times, 22.6-25 kg/m2 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.
UNASSIGNED: 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.
■这项随机双盲安慰剂对照试验是在DIR进行的,DUHS的Ojha和LEJ校园从2019年11月到2021年5月。所有年龄超过40岁的女性均接受首次乳房X线照片(筛查或诊断)。在639名参与者中,对乙酰氨基酚组包括321个,安慰剂组包括318个。两组患者都口服了由陶氏药房定制的药物。乳房X线照相术过程中感觉到的疼痛程度是使用视觉模拟量表测量的结果变量。
■在506名(79.19%)女性中发现了总体疼痛。安慰剂组的女性疼痛明显高于扑热息痛组的患者,即,280(55.3%)和226(44.7%)(p值<0.001)。在调整其他协变量后,安慰剂组女性的疼痛几率是扑热息痛组女性的3.64倍(OR3.64,95%CI2.31~5.74).此外,>25kg/m2的BMI是2.84倍,22.6-25kg/m2BMI是2.29倍,nulligravida是3.56倍,绝经状态是2.23倍,绝经前状态为4.51倍,乳腺癌家族史是患者疼痛的2.33倍。两组均未观察到试验后并发症。
■发现在乳房X线照相术之前使用扑热息痛是减轻女性疼痛的有效干预措施。临床试验:标识符:NCT04381104。