Titration mit oralem transmukosalem Fentanylcitrat und Morphinsulfat zur Dosisfindung einer Behandlung mit transdermalem Fentanylpflaster

Patients who needed a treatment with opioids of WHO level 3 due to increasing pain were included in this study. We compared oral transmucosal fentanyl citrate (OTCF) with immediate release morphine (IRM) for the dose finding of a transdermal fentanyl (TF) treatment. Up to now commonly morphine either orally, subcutaneously or via Patient Controlled Analgesia (PCA) intravenously was used for dose titration. However, conversion ratio tables were necessary to calculate the ratio of morphine to TF. OTFC represents an alternative to morphine for the dose finding titration procedure. Using the same drug OTFC is basically the ideal top-up medication for patients treated with TF and might also present the ideal medication for dose titration. As well as the confirmation of the chosen conversion rate of 1:1 of OTFC on TF another objective was to define the time needed to obtain sufficient pain relief. The previous opioid therapy was stopped after inclusion of the patients and a randomised assignment was carried out into one of the two treatment groups. The dose titration was carried out in this group with OTFC 200 µg and in the other group with IRM 10 mg. On day 1 the dose for TF could be determined from the amount of on-demand-medication the patients had taken within the first 24 hours. The conversion was carried out with the factor 100:1 of oral morphine to transdermal fentanyl and with the factor 1:1 of transmucosal to transdermal fentanyl. Of altogether 60 patients in the course of the study 25 completed the titration phase in the IRM group and 19 patients in the OTFC group. Eighty-four percent completed titration with a good result in the IRM group and 89.4 % in the OTFC group. Four patients of the IRM group needed further dose corrections and in comparison with 2 patients in the OTFC group. Fiftyseven percent achieved an optimal titration result with a stable dose from the beginning in the OTFC group and 52% in the IRM group. The faster onset time which was shown at OTFC in many studies could be confirmed considerably also in our collective. The average pain intensity was significantly lower in both groups at the end of the study in comparison with the beginning. The average pain in the beginning was 6.19 ± 1.83 points in the OTFC group on a numeric rating scale (NRS) and 4.19, ± 2.25 (p = 0.003) at the end of the study (IRM group: 6.00 ± 1.73 versus 3.26, ± 1.99 (p = 0.000). Adverse events (AE) were documented in 45 % of all 60 patients during the titration phase. AE were mainly nausea, tiredness and dizziness in both groups and corresponded to typical side effects of the study medication. The chosen conversion rate of 1:1 of OTFC on transdermal fentanyl has been confirmed and can be recommended. No severe adverse events (SAE) could be observed in the titration phase. The higher number of drop-outs ocured in the OTFC group. While there was only on drop-out in the IRM group because of side effects of the titration medication, in the OTFC group there were drop-outs because of side effects, a lack of effect or disgust in 8 patients. The application of IRM is easier. At least, by the correct application of OTFC side effects like lesions of the oral mucosa can be avoided. Dose titration can be performed both with OTFC and IRM successfully within 24 hours.

Grantor dc:publisher

Publikationsserver der RWTH Aachen University

Year dc:date

2012

Author dc:creator

• Eimer, Sebastian

Contributors dc:contributor

• Elsner, Frank

• info:eu-repo/classification/ddc/610
• Titration
• Fentanyl
• Medizin
• Fentanylcitrat
• fentanyl citrate

Statement dc:rights

• info:eu-repo/semantics/openAccess

Language dc:language

ger

Identifier

https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-124495%22

OAI identifier oai:identifier

oai:publications.rwth-aachen.de:63033