Oral metamizol (1 g and 2 g) versus ibuprofen and placebo in the treatment of lower third molar surgery pain: randomised double-blind multi-centre study. Cooperative Study Group

Abstract

Objective: To assess the efficacy of metamizol 1 g and 2 g in the relief of pain after surgical extraction of the lower third molar, and to compare the therapeutic effect with that of ibuprofen 600 mg or placebo.

Methods: A total of 253 patients aged between 18 years and 60 years who had undergone extraction of the lower third molar (types II-IV) under local anaesthesia, up to a maximum of 108 mg of mepivacaine, were randomly assigned to a single oral dose of a new galenic form (drinkable vials) of metamizol 1 g (n = 75), metamizol 2 g (n = 72), ibuprofen 600 mg (n = 74) or placebo (n = 32). Pain intensity was evaluated by a 100-mm visual analogue scale. To enter the study, a pain level of 50 mm or more was required. The duration of the trial was 1 h. Assessments were carried out at 15, 30 and 60 min after treatment.

Results: The analgesic efficacy of metamizol 2 g was significantly better than ibuprofen and placebo with regard to all evaluated parameters. The values of the pain intensity difference at 15 min, the percentage of patients with a decrease of 50% or more on the visual analogue scale at 60 min and the sum of pain intensity differences at 60 min showed metamizol 2 g to be significantly more effective than metamizol 1 g. In general, metamizol 1 g was as effective as ibuprofen 600 mg. The analgesic efficacy of placebo was significantly lower than that of all active treatments. A lower number of patients treated with metamizol 1 g (n = 1) or metamizol 2 g (n = 1) needed rescue medication than those given ibuprofen (n = 7) or placebo (n = 5). No serious adverse effects developed and none of the patients had to leave the study for this reason.

Conclusions: The model of the lower third molar, for which the analgesic outcome referred to the first hour after drug administration, demonstrated that the analgesic efficacy of oral metamizol 2 g was significantly higher than that of ibuprofen 600 mg or placebo. Metamizol 1 g and ibuprofen 600 mg showed a similar therapeutic effect. All regimens were as well tolerated as placebo.