Naproxen Sodium, Extra-Strength Tylenol and Placebo in the treatment of pain secondary to Dental Impaction Surgery
This was a single-dose, randomized, parallel, double-blind, singlecenter,
placebo and active treatment-controlled study designed for
225 subjects. Subjects were randomly assigned at a ratio of 2:2:1 to
receive two capsules of either naproxen sodium, acetaminophen, or
placebo. Subjects rated their pain intensity on categorical (CAT) and
visual analog scales (VAS). Pain relief was rated on categorical scales.
Pain intensity was evaluated immediately prior to study drug
administration. Pain intensity, pain relief, and "pain half gone" were
evaluated at 20, 30, 40, and 60 minutes and hourly thereafter for 12
hours following study drug administration.
: - Healthy males and females atleast 15 years of age with at least moderate post operative pain associated with surgical removal of three or four third molars (including at least one mandibular partial or complete bony impaction) were enrolled in the study.
No Exclusion Criteria Available
Single-Dose Study Comparing the Safety, Efficacy and Duration of Naproxen Sodium, Extra-Strength Tylenol and Placebo in the treatment of pain secondary to Dental Impaction Surgery