A randomized, double-blind, placebo-controlled multicentre study to evaluate the efficacy and safety of diclofenac 4% spray gel in the treatment of acute uncomplicated ankle sprain.

Objective: A prospective, randomized, double-blind, placebo-controlled, parallel-group multicentre study to evaluate the efficacy and safety of diclofenac 4% spray gel for the treatment of acute, uncomplicated ankle sprain.

Methods: Outpatients with acute, uncomplicated, one-sided ankle sprain were randomly assigned to receive diclofenac 4% spray gel or placebo (vehicle) three times daily for 14 ± 1 days. The main efficacy endpoint was the intra-individual response to treatment (≥ 50% decrease in swelling of the injured ankle after a treatment period of ≤ 10 days).

Analgesic efficacy and tolerability of ketoprofen lysine salt vs paracetamol in common paediatric surgery. A randomized, single-blind, parallel, multicentre trial.

Background: In this study, we compared the analgesic efficacy of ketoprofen lysine salt (OKi) suppositories) vs paracetamol, in children undergoing minor surgery. We also studied the side-effects of the treatment.

Methods: Eighty-five children of both sexes, aged 6-14 years, were enrolled in a multicentre, randomized, single-blind, parallel-group study design.