A Randomized Clinical Trial Comparing 2 Ibuprofen Formulations in Patients with Acute Odontogenic Pain

Introduction Ibuprofen sodium dihydrate, a new formulation of ibuprofen, was introduced with the claim of faster onset of analgesia. Most of the data on this new ibuprofen formulation are drawn from studies using the oral surgery model. Because this model differs significantly from the endodontic pain model, we conducted a study comparing ibuprofen sodium dihydrate with conventional ibuprofen acid in endodontic pain patients. Methods This randomized, double-masked study recruited subjects experiencing moderate to severe pain from a tooth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis (n = 41). Subjects were randomized to receive 400 mg ibuprofen acid (Advil; Pfizer, Madison, NJ) or an equivalent dose of 512 mg ibuprofen sodium dihydrate (Advil Sodium, Pfizer). The outcome measures were time to onset of 50% pain relief recorded using a stopwatch, reduction in spontaneous pain experienced on a 100-mm visual analog scale, and change in mechanical allodynia measured using a bite force transducer. The last 2 measures were obtained before and 60 minutes after administration of the drug. Results The median time to onset of 50% pain relief after administration of ibuprofen sodium dihydrate was significantly faster compared with ibuprofen acid (26.5 vs 44 minutes, P = .08). Ibuprofen sodium dihydrate provided a greater reduction in spontaneous pain (50.8% vs 33.3%, P < .05) and mechanical allodynia (15% vs 9%, P > .05). Conclusions In endodontic pain patients, a single dose of ibuprofen sodium dihydrate provides faster onset of pain relief and a greater reduction in spontaneous and evoked pain compared with ibuprofen acid.