BACKGROUND: Pain management is an important component in the postoperative period following discectomy. AIMS: We hypothesized that mesalamine considering its better safety profile, is likely to be a better choice, if it would be as effective as ibuprofen in controlling post-discectomy pain. SETTINGS AND DESIGN: A double-blind randomized controlled trial was performed on patients who underwent lumbar discectomy surgery. MATERIALS AND METHODS: Of the 58 patients who had lumbar discectomy, 27 patients were randomized to oral ibuprofen 500 mg and 31 patients to mesalamine 400 mg, three times a day for nine days following surgery. There was no placebo group. Severity of pain was assessed by using 10- cm visual analogue scale (VAS), once before operation and for nine days after. STATISTICAL ANALYSIS: Mean +/- SD pain scores were compared between groups and the statistical difference was estimated by Student's test using SPSS (Version 13). We also calculated the power of each t-test. Repeated measure ANOVA was performed for measuring the effect of time. RESULTS:The age range of the patients was 35 to 60 years (mean: 42.2 years). Mean +/- SD preoperative pain scores for ibuprofen or mesalamine-treated groups were 7.852 +/- 2.441 and 7.806 +/- 2.892, respectively. At the end of day 9, mean +/- SD of pain score was 2.704 +/- 2.284 and 2.717 +/- 2.273 for ibuprofen and mesalamine-treated groups respectively. Both drugs significantly reduced postoperative pain and there was no statistically significant difference between the two groups. CONCLUSIONS: Since both drugs showed almost equal analgesic effect, considering its safety profile mesalamine, seems to be the preferred choice to alleviate post-discectomy surgery pain.
RCT Entities:
BACKGROUND:Pain management is an important component in the postoperative period following discectomy. AIMS: We hypothesized that mesalamine considering its better safety profile, is likely to be a better choice, if it would be as effective as ibuprofen in controlling post-discectomy pain. SETTINGS AND DESIGN: A double-blind randomized controlled trial was performed on patients who underwent lumbar discectomy surgery. MATERIALS AND METHODS: Of the 58 patients who had lumbar discectomy, 27 patients were randomized to oral ibuprofen 500 mg and 31 patients to mesalamine 400 mg, three times a day for nine days following surgery. There was no placebo group. Severity of pain was assessed by using 10- cm visual analogue scale (VAS), once before operation and for nine days after. STATISTICAL ANALYSIS: Mean +/- SD pain scores were compared between groups and the statistical difference was estimated by Student's test using SPSS (Version 13). We also calculated the power of each t-test. Repeated measure ANOVA was performed for measuring the effect of time. RESULTS: The age range of the patients was 35 to 60 years (mean: 42.2 years). Mean +/- SD preoperative pain scores for ibuprofen or mesalamine-treated groups were 7.852 +/- 2.441 and 7.806 +/- 2.892, respectively. At the end of day 9, mean +/- SD of pain score was 2.704 +/- 2.284 and 2.717 +/- 2.273 for ibuprofen and mesalamine-treated groups respectively. Both drugs significantly reduced postoperative pain and there was no statistically significant difference between the two groups. CONCLUSIONS: Since both drugs showed almost equal analgesic effect, considering its safety profile mesalamine, seems to be the preferred choice to alleviate post-discectomy surgery pain.