BACKGROUND: Therapeutic pain is one of the most important outcome measures in surgery. Comparative studies investigating ketorolac efficiency in ambulatory surgery have generally been restricted to IV administration. We compared analgesic effectiveness of sublingual ketorolac and metamizole in short stay surgery. METHODS: This was a randomized single-blind clinical trial. All patients received either a three-dose (30 mg) of sublingual ketorolac or 1 g of IV metamizole, respectively. We evaluated pain with a visual/analog scale (VAS). Side effects were also recorded. Statistical analysis included t-test or Mann-Whitney U test and Fisher exact test or chi(2). Absolute risk reduction (ARR), odds ratio (OR), confidence interval (CI), relative risk ratio (RRR) and numbers needed to treat (NNT) were also evaluated. RESULTS: Rescue doses of analgesics were greater in patients receiving metamizole although the difference was not significant (p = 0.286). Mean VAS score was lower in the ketorolac group at 8 h after surgery, with no statistical difference (p = 0.06). ARR for severe pain score was almost 5% (OR = 1.78). Adverse effects did not show differences between groups (p = 0.642). CONCLUSIONS:Ketorolac and metamizole have comparable effects and can be safely used in ambulatory settings.
RCT Entities:
BACKGROUND: Therapeutic pain is one of the most important outcome measures in surgery. Comparative studies investigating ketorolac efficiency in ambulatory surgery have generally been restricted to IV administration. We compared analgesic effectiveness of sublingual ketorolac and metamizole in short stay surgery. METHODS: This was a randomized single-blind clinical trial. All patients received either a three-dose (30 mg) of sublingual ketorolac or 1 g of IV metamizole, respectively. We evaluated pain with a visual/analog scale (VAS). Side effects were also recorded. Statistical analysis included t-test or Mann-Whitney U test and Fisher exact test or chi(2). Absolute risk reduction (ARR), odds ratio (OR), confidence interval (CI), relative risk ratio (RRR) and numbers needed to treat (NNT) were also evaluated. RESULTS: Rescue doses of analgesics were greater in patients receiving metamizole although the difference was not significant (p = 0.286). Mean VAS score was lower in the ketorolac group at 8 h after surgery, with no statistical difference (p = 0.06). ARR for severe pain score was almost 5% (OR = 1.78). Adverse effects did not show differences between groups (p = 0.642). CONCLUSIONS:Ketorolac and metamizole have comparable effects and can be safely used in ambulatory settings.
Authors: Thomas Kötter; Bruno R da Costa; Margrit Fässler; Eva Blozik; Klaus Linde; Peter Jüni; Stephan Reichenbach; Martin Scherer Journal: PLoS One Date: 2015-04-13 Impact factor: 3.240