Titre du document / Document title

Oral metamizol (1 g and 2 g)

Auteur(s) / Author(s)

Cooperative Study Group
PLANAS M. E. ⁽¹⁾ ; GAY-ESCODA C. ⁽¹⁾ ; BAGAN J. V. ⁽²⁾ ; SANTAMARIA J. ⁽³⁾ ; PENARROCHA M. ⁽⁴⁾ ; DONADO M. ⁽⁵⁾ ; PUERTA J. L. ⁽⁶⁾ ; GARCIA-MAGAZ I. ⁽⁶⁾ ; RUIZ J. ⁽⁶⁾ ; ORTIZ P. ⁽⁶⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Faculty of Odontology, University of Barcelona, Barcelona, ESPAGNE
⁽²⁾ Department of Odontology, Hospital General Universitario, Valencia, ESPAGNE
⁽³⁾ Service of Maxillofacial Surgery, Hospital de Cruces, Universidad del Pais Vasco, Bilbao, ESPAGNE
⁽⁴⁾ Faculty of Odontology, Universidad de Valencia, Valencia, ESPAGNE
⁽⁵⁾ Faculty of Odontology, Universidad Complutense, Madrid, ESPAGNE
⁽⁶⁾ Departamento Medico, Boehringer Ingelheim Espana, S.A., Avda. Brasil 6, 28020 Madrid, ESPAGNE

Résumé / 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 I 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 I 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 I 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 I g and ibuprofen 600 mg showed a similar therapeutic effect. All regimens were as well tolerated as placebo.

Revue / Journal Title

European journal of clinical pharmacology   ISSN 0031-6970 

Source / Source

1998, vol. 53, n^o6, pp. 405-409 (17 ref.)

Langue / Language

Anglais

Editeur / Publisher

Springer, Berlin, ALLEMAGNE  (1970) (Revue)

Mots-clés anglais / English Keywords

Metamizole sodium ; Ibuprofen ; Analgesic ; Oral administration ; Single dose ; Comparative study ; Human ; Chemotherapy ; Treatment ; Dose activity relation ; Pain ; Surgery ; Tooth ; Molar tooth ; Dentistry ; Arylacetic acid derivatives ; Dental disease ;

Mots-clés français / French Keywords

Métamizole sodique ; Ibuprofène ; Analgésique ; Voie orale ; Dose unique ; Etude comparative ; Homme ; Chimiothérapie ; Traitement ; Relation dose réponse ; Douleur ; Chirurgie ; Dent ; Molaire ; Dentisterie ; Arylacétique acide dérivé ; Dent pathologie ;

Mots-clés espagnols / Spanish Keywords

Metamizol sódico ; Ibuprofeno ; Analgésico ; Vía oral ; Dosis única ; Estudio comparativo ; Hombre ; Quimioterapia ; Tratamiento ; Relación dosis respuesta ; Dolor ; Cirugía ; Diente ; Molar ; Odontología ; Arilacético ácido derivado ; Diente patología ;

Localisation / Location

INIST-CNRS, Cote INIST : 13739, 35400007899884.0030