Purpose: To test the hypothesis that premedication with acetaminophen, ibuprofen, and/or 4% lidocaine gel would decrease discomfort and improve satisfaction with screening mammography in women who expect a higher level of discomfort.
Materials and methods: In this HIPAA-compliant, institutional review board-approved, prospective, double-blinded, placebo-controlled clinical trial, 418 women aged 32-89 years who expected substantial discomfort with screening mammography were randomly divided to receive premedication with acetaminophen, ibuprofen, and/or 4% lidocaine gel. Subjects provided informed written consent. The primary outcome was discomfort. Secondary outcomes were satisfaction and plans for future mammography on the basis of discomfort. Subjects completed structured questionnaires with visual analog scales to measure discomfort and satisfaction. A generalized linear mixed-models framework was used to assess the effect of medications on discomfort during mammography, and satisfaction with technologist and machine combinations was included as a random effect. The "plans for mammography next year" outcome was modeled by using a binary distribution and logit link function.
Results: Discomfort was significantly lower in the lidocaine gel group (P = .01). Satisfaction was significantly negatively correlated with discomfort (P < .001). Satisfaction and whether or not the subject had delayed her mammography because of fear of discomfort had significant effects on plans to undergo mammography next year (P < .001 for both). There were significant differences in discomfort between different combinations of technologists and machines.
Conclusion: Premedication with 4% lidocaine gel significantly reduced discomfort during screening mammography, and reduced discomfort may improve the likelihood of future mammographic screening and early detection of breast cancer.