Die neu standardisierte Morphinlösung NRF 2.4 zur Dosisfindung bei Ersteinstellung mit Morphin und als Zusatzmedikation bei einer Basistherapie mit retardierten Morphinsulfattabletten

Summary

The standardized viscose-morphine hydrochloride solution listed under no. 2.4 in the New German Prescription Formulary (Neues Rezepturformularium; NRF) does not contain any pharmacologically active substance other than morphine. It can be prescribed in concentrations of 0.2% and 2% and can be kept for 1 year without refrigeration. In particularly severe cases of illness up to 20000 mg morphine in the form of this solution can be prescribed for use over 30 days.

In the context of a prospective clinical trial, this preparation was tested in 98 patients. During the initial adjustment the patients received the baseline amount of morphine they were estimated to need on the basis of the current pain intensity and the previous treatment. At this stage they received morphine in the form of sustained release tablets at intervals of 8–12 h. If needed, they were allowed half the amount of morphine contained in their single dose of morphine tablets in the form of the solution in addition in the presence of pain, but not more frequently than every 4 h. The analgesic effect began 10–20 min after ingestion of the solution and persisted for 3–4 h. Neither the use of the morphine solution as such nor the possible doubling of the dose of morphine by its additional use as adjuvant medication led to any unusual effects of morphine or to any unwanted effects that were enhanced in a clinically relevant manner. The combination of sustained release morphine tablets and the morphine solution made it possible to restrict the adjustment phase to an average of 4.8 days, and 60% of the patients were free of pain after as little as 24 h. The flavour of the morphine solution and the way its use was managed were well accepted by 90% of the patients. Meanwhile, positive results of such therapy have been obtained in a further 200 children and adults.