Abstract
Purpose
This study compared the sedative effects of sublingual tablet midazolam (Roche Dormicum 7.5 mg) with the oral route as premedication.
Methods
One hundred ASA physical status I and II gynaecological patients were randomly selected to receive a 7.5 mg tablet of midazolam either sublingually or orally as premedication about one hour before elective surgery. There were 50 patients in each group. The degree of sedation was assessed according to the Ramsay scale initially and then at 20. 30, 45 and 60 min intervals by a second observer blinded to the route of administration. The time for complete drug dissolution was studied in the sublingual group by the inspection of tablet residue under the tongue every five minutes for 20 min, then the patients were interviewed regarding their acceptance of the taste.
Results
The sedation scores in the sublingual group were higher than in the oral group at 30 and 60 min after drug administration. (P=0.0054 and P=0.008) Seventy-two percent of the sublingual group had complete drug dissolution within 10 min and 64% of the patients in the sublingual group found the tablet acceptable with regard to its taste.
Conclusion
Midazolam 7.5 mg sublingual is a more effective pre-anaesthetic sedative than by the oral route.
Résumé
Objectif
Comparer les effets sédatifs du midazolam administré par la voie sublinguale (Dormicum Roche 7,5 mg) avec la voie orale.
Méthodes
En gynécologie, 100 patientes ASA I et II ont été choisies aléatoirement pour recevoir en prémédication du midazolam en comprimé oral ou sublingual de 7,5 mg environ une heure avant une chirurgie élective. Chaque groupe comptait 50 patientes. La sédation était évaluée d’abord sur l’échelle de Ramsay et l’évaluation était répétée à des intervalles de 20, 30, 45 et 60 min par un observateur neutre. L’intervalle jusqu’à la dissolution complète du compnmé sublingual était estimé par l’inspection du résidu oral toutes les cinq minutes pour 20 min. Par la suite, on demandait l’opinion des patientes sur son goût.
Résultats
Les scores de sédation du groupe sublingual étaient plus élevés dans le groupe oral 30 et 60 min après l’administration (P = 0, 0054 et P = 0, 008). Soixante-douze pour cent des patientes du groupe sublingual ont trouvé le goût du comprimé sublingual acceptable.
Conclusion
En sédation préanesthésique. l’administration sublinguale de midazolam 7.5 mg est plus efficace que l’administration orale.
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The study was supported by Roche (Singapore).
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Lim, T.W., Thomas, E. & Choo, S.M. Premedication with midazolam is more effective by the sublingual than oral route. Can J Anaesth 44, 723–726 (1997). https://doi.org/10.1007/BF03013385
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DOI: https://doi.org/10.1007/BF03013385