A study to compare ibuprofen effervescent granules with ibuprofen tablets in the treatment of acute dental pain.

PURPOSE OF STUDY

To compare both the speed of onset and efficacy of the analgesia produced by the effervescent granule formulation with that produced by the conventional-release tablet formulation of ibuprofen in patients suffering acute dental pain and to record the incidence and severity of any adverse events.

POPULATION STUDIED

Dental out-patients of either sex and over 16 years of age requiring surgical removal of unilateral or bilateral lower third molar teeth under general anaesthesia as day cases.

METHODS

A total of 50 patients received the effervescent granules formulation of ibuprofen 600 mg (Brufen Granules) as study treatment and 50 received the 600 mg tablet formulation in this investigator-blind, parallel-group multiple-dose study. Surgery was performed under general anaesthesia by one or two dental surgeons. Patients received either one sachet of ibuprofen granules or one tablet of ibuprofen at six-hourly intervals for up to 24 hours once post-operative pain became moderate to severe.

FINDINGS

Both treatments were shown to be efficacious in treating post-operative dental pain. The granules were found to give significantly better pain relief in the first 30 minutes following the first dose. This may be owing to a more rapid absorption from the granules formulation in these patients and/or a local action of ibuprofen in solution in the mouth.

CONCLUSION

The effervescent soluble form of ibuprofen (Brufen Granules) is preferable to the conventional tablet form in managing the immediate dental pain experienced post-operatively by most patients because of its faster onset of action.