Analgesic efficacy and safety of Fenbufen following surgical removal of a lower wisdom tooth: a comparison with acetylsalicylic acid and placebo.

In a double-blind clinical trial a new, non-steroidal anti-inflammatory agent with analgesic properties, Fenbufen, was compared to acetylsalicylic acid (ASA) and placebo. Six hundred (600) out-patients, following surgical removal of an impacted lower wisdom tooth, were divided into three groups and randomly given either Fenbufen (500 mg capsules), ASA (750 mg capsules), or placebo. One capsule was taken immediately after the surgical procedure, followed by another capsule every 6 hours. The duration of treatment was 24 hours. Thus, a total of 4 capsules were taken. Self-evaluation forms were provided to the patients and were returned to the investigators the following day. The results were statistically analyzed. Both Fenbufen and ASA were statistically superior (p less than or equal to 0.01) to placebo in relieving pain. A comparison of the Fenbufen and ASA groups demonstrated a statistically significant (p less than or equal to 0.05) superiority for Fenbufen in relieving pain. Also sleep was less disturbed in the Fenbufen group. Side-effects reported were few, minor in character, and fewer in number in the Fenbufen group.

RCT Entities:   Population Interventions Outcomes