Evaluation of the analgesic activity and tolerability of aceclofenac in the treatment of post-episiotomy pain.

The activity and tolerability of aceclofenac, a new arylacetic anti-inflammatory drug, was assessed in the treatment of post-episiotomal pain in a controlled double-blind study with paracetamol. Aceclofenac was administered in single 100 mg doses and paracetamol in single 650 mg doses (both drugs in tablet form) to 60 women aged between 18 and 38 years with post-episiotomal pain. They were randomised into two groups of 30 patients. The severity of the pain was assessed by the patients using an analog visual test (Huskisson's test) before treatment and 0.5, 1,2,3,4,5 and 6h after receiving the drug. At the end of the study, the investigator questioned the patients about the evolution of their pain and any side-effects that might have appeared during the 6 h of observation. On the basis of their replies, the investigator evaluated the pain on a semi-quantitative scale of 5 points. The tolerability was assessed on the basis of the appearance of any undesired effects. The patients treated with drug A* showed a progressive and marked reduction of their pain with a significant difference from the baseline score after the second hour of observation (Huskisson's test) and after the first hour (physician's assessment with the 5-point scale), respectively. The antalgic effect of drug B showed a similar evolution over time to drug A but the analgesic efficacy seemed to be much less.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes