OBJECTIVES: To evaluate the analgesic advantage of tramadol in patients undergoing transrectal biopsy of the prostate in ambulatory settings compared with topical analgesia. METHODS: A total of 77 patients scheduled for prostate biopsy were randomly assigned to receive 5% lidocaine ointment 5 mL per rectum 10 minutes before the procedure (group 1) or lidocaine ointment combined with tramadol drops 1 mg/kg per os 40 minutes before the procedure (group 2). Pain severity, main cardiorespiratory parameters, difficulty of the procedure, procedure-related side effects, and complications were analyzed. RESULTS: No significant respiratory or hemodynamic disturbances were observed. The pain severity, as measured on a visual analog scale, was significantly lower in group 2 (P = 0.038), and the rate of overall satisfaction with the level of analgesia was significantly greater (P = 0.027). The urologist's assessment of "very easy" was assigned to 77.1% of procedures in group 2 compared with 54.8% of procedures in group 1 (P = 0.04). The rate of side effects in both groups was similar at 9.5% versus 11.4% (P = 0.785). CONCLUSIONS: The combination of lidocaine per rectum with tramadol per os is a simple and safe technique providing good analgesic effect and, therefore, can be recommended for transrectal ultrasound-guided prostate biopsy.
RCT Entities:
OBJECTIVES: To evaluate the analgesic advantage of tramadol in patients undergoing transrectal biopsy of the prostate in ambulatory settings compared with topical analgesia. METHODS: A total of 77 patients scheduled for prostate biopsy were randomly assigned to receive 5% lidocaine ointment 5 mL per rectum 10 minutes before the procedure (group 1) or lidocaine ointment combined with tramadol drops 1 mg/kg per os 40 minutes before the procedure (group 2). Pain severity, main cardiorespiratory parameters, difficulty of the procedure, procedure-related side effects, and complications were analyzed. RESULTS: No significant respiratory or hemodynamic disturbances were observed. The pain severity, as measured on a visual analog scale, was significantly lower in group 2 (P = 0.038), and the rate of overall satisfaction with the level of analgesia was significantly greater (P = 0.027). The urologist's assessment of "very easy" was assigned to 77.1% of procedures in group 2 compared with 54.8% of procedures in group 1 (P = 0.04). The rate of side effects in both groups was similar at 9.5% versus 11.4% (P = 0.785). CONCLUSIONS: The combination of lidocaine per rectum with tramadol per os is a simple and safe technique providing good analgesic effect and, therefore, can be recommended for transrectal ultrasound-guided prostate biopsy.