Randomized Double-Blind Placebo-Controlled Clinical Trial Testing Ketorolac Tromethamine for Reducing the Pain and Discomfort Experienced during Mammography.

Abstract

Abstract OBJECTIVE: To study the possibility of reducing the pain and discomfort experienced during mammography, by means of using an analgesic as premedication. PATIENTS AND METHODS: This was a randomized double-blind placebo-controlled clinical trial testing ketorolac tromethamine for reducing the pain and discomfort experienced during mammography. There were 308 participants in the study, who all signed a free and informed consent statement. Of these, 153 patients (group 1) received 10 mg of ketorolac tromethamine orally and 155 (group 2) received placebo orally, 60 minutes before undergoing mammographic examination. After taking the medication and while waiting to undergo the procedure, the patients themselves filled out a form asking about personal data and possible factors relating to pain and discomfort while undergoing mammography. After the examination, the patients subjectively assessed the pain and discomfort experienced during the examination using a visual analog scale (VAS) graded from zero to ten. The statistical analysis consisted of characterizing the groups using absolute and relative frequencies and comparing the dependent and independent variables between the groups using the chi-squared association test, with Yates correction when necessary. RESULTS: The mean VAS pain level presented by the patients was 3.36 and the median was 2.90. It was observed that 51 (16.6%) of the patients did not present any pain, 106 (34.4%) presented mild pain, 94 (30.5%) moderate pain, 40 (13%) severe pain and 17 (5.5%) intolerable pain. With regard to discomfort, 68 (54.9%) reported tolerable discomfort, 63 (20.5%) a lot of discomfort and 8 (2.6%) intolerable discomfort. Among the factors related to pain, only the presence of previous mastalgia was significant (p < 0.05). Somnolence was the adverse event most present: 2.6 and 5.8% in the ketorolac and placebo groups, respectively. CONCLUSIONS: The use of 10 mg of ketorolac tromethamine did not have any influence regarding reduction of the pain and discomfort experienced by the patients during mammography, when compared with placebo. Among the factors studied, the only one associated with greater possibility of pain and discomfort while undergoing mammography was a history of mastalgia. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4014.