A Randomized Clinical Trial Comparing 2 Ibuprofen Formulations in Patients with Acute Odontogenic Pain.
BACKGROUND
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.
Private Practice, Rochester, NY.
Tanjit
T
Taggar
Department of Periodontology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Di
D
Wu
Department of Endodontics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: Asma_Khan@unc.edu.
Asma A
AA
Khan
D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D014098:Toothache / Q000188:drug therapy*
D018712:Analgesics, Non-Narcotic; D007052:Ibuprofen
Ibuprofen; mechanical allodynia; nonsteroidal anti-inflammatory drugs; pain; pulpitis