PURPOSE: The primary purpose of the present study was to compare the antiinflammatory effectiveness of rofecoxib with that of ibuprofen in the first 5 days after uterine artery embolization (UAE). The secondary aim was to compare pain levels and narcotic use among patients treated with different embolic agents. MATERIALS AND METHODS: From July 2003 to June 2004, 68 UAE procedures were performed by one of the authors (D.M.H.). Of this group, 50 women agreed to participate in this study. Exclusion criteria were limited to contraindication to either drug or current steroid or nonsteroidal antiinflammatory drug use. In a randomized, double-blinded fashion, patients received a numbered pill box that contained one of the two agents and its placebo counterpart. Four times per day for 5 days, patients recorded their level of pain on a visual analog scale and the amount of narcotic analgesic drug needed at that time. Score sheets were returned by mail after completion. During the course of the study, three embolic agents (Gold Embospheres, Contour SE particles, and Embospheres) were used in succession, with similar numbers of patients in each group. RESULTS:Four patients were excluded from analysis: two who were readmitted to the hospital for treatment of pain (one treated with each antiinflammatory medication) and two who failed to complete their score sheets. Subject demographics were very similar with respect to antiinflammatory drug treatment and embolic agent, except that the average age of patients in the Embosphere group was 6 years older than in the Embosphere Gold and Contour SE groups (P= .02). There was no difference in the pain level and narcotic drug intake between the two drug arms, but among embolic agents, the Embosphere Gold group tended to have a higher overall average pain score (P = .12), and the two patients readmitted were in this group. Patients in the Contour SE group tended to use a lower amount of narcotic drug than those in the other two embolic agent groups (P = .09). CONCLUSIONS: There was no difference between rofecoxib and ibuprofen with respect to postprocedural pain or narcotic use after UAE. Embolic agent appeared to have a greater impact, with patients in the Embosphere Gold group reporting higher pain scores and those in the Contour SE group requiring a lower amount of narcotic drug than those in the Embosphere Gold or Embosphere groups.
RCT Entities:
PURPOSE: The primary purpose of the present study was to compare the antiinflammatory effectiveness of rofecoxib with that of ibuprofen in the first 5 days after uterine artery embolization (UAE). The secondary aim was to compare pain levels and narcotic use among patients treated with different embolic agents. MATERIALS AND METHODS: From July 2003 to June 2004, 68 UAE procedures were performed by one of the authors (D.M.H.). Of this group, 50 women agreed to participate in this study. Exclusion criteria were limited to contraindication to either drug or current steroid or nonsteroidal antiinflammatory drug use. In a randomized, double-blinded fashion, patients received a numbered pill box that contained one of the two agents and its placebo counterpart. Four times per day for 5 days, patients recorded their level of pain on a visual analog scale and the amount of narcotic analgesic drug needed at that time. Score sheets were returned by mail after completion. During the course of the study, three embolic agents (Gold Embospheres, Contour SE particles, and Embospheres) were used in succession, with similar numbers of patients in each group. RESULTS: Four patients were excluded from analysis: two who were readmitted to the hospital for treatment of pain (one treated with each antiinflammatory medication) and two who failed to complete their score sheets. Subject demographics were very similar with respect to antiinflammatory drug treatment and embolic agent, except that the average age of patients in the Embosphere group was 6 years older than in the Embosphere Gold and Contour SE groups (P= .02). There was no difference in the pain level and narcotic drug intake between the two drug arms, but among embolic agents, the Embosphere Gold group tended to have a higher overall average pain score (P = .12), and the two patients readmitted were in this group. Patients in the Contour SE group tended to use a lower amount of narcotic drug than those in the other two embolic agent groups (P = .09). CONCLUSIONS: There was no difference between rofecoxib and ibuprofen with respect to postprocedural pain or narcotic use after UAE. Embolic agent appeared to have a greater impact, with patients in the Embosphere Gold group reporting higher pain scores and those in the Contour SE group requiring a lower amount of narcotic drug than those in the Embosphere Gold or Embosphere groups.