title: [Dose-finding for treatment with a transdermal fentanyl patch : Titration with oral transmucosal fentanyl citrate and morphine sulfate].
abstract: To date, no studies investigating titration with oral transmucosal fentanyl for the dose-finding of transdermal fentanyl treatment have been published. In an open randomized study 60 patients with chronic malignant (n = 39) or nonmalignant pain (n = 21), who required opioid therapy according to step three of the guidelines of the World Health Organization (WHO), were investigated. In two groups of 30 patients each titration with immediate release morphine (IRM) or oral transmucosal fentanyl citrate (OTFC) was undertaken. For measurement purposes the Brief Pain Inventory (BPI) and Minimal Documentation System (MIDOS) were used. After a 24-h titration phase, in which patients documented the intensity of pain, nausea, and tiredness, treatment with transdermal fentanyl was evaluated over a 10-day period by means of the necessary dose adaptation (responder ≤ 1 dose adaptation; conversion formula 1:1 [OTFC group] vs 100:1 [IRM group]).The pain reduction over the first 24 h (titration phase) did not differ significantly between the groups. The number of responders (17 OTFC vs. 21 IRM) over the 10-day period did not show any difference either. In both groups there was a significant reduction in pain intensity (p < 0.001). Over the course of the study, there were significantly more drop-outs because of adverse effects in the OTFC group than in the IRM group (8 vs 1, p = 0.028).Oral transmucosal fentanyl citrate can be applied for the titration of transdermal fentanyl, but it does not show any clinically relevant advantage. For example, the risk of side effects-induced drop-outs was greater in the present study. Whether the unnecessary opioid switching to treat chronic pain and breakthrough pain is advantageous with regard to minimizing conversion errors cannot be definitively answered within the scope of this study.
authors.affiliation: Klinik für Palliativmedizin, Universitätsklinikum Bonn, Bonn, Deutschland. martin.muecke@ukb.uni-bonn.de.|Institut für Hausarztmedizin, Universitätsklinikum Bonn, Bonn, Deutschland. martin.muecke@ukb.uni-bonn.de.
authors.forename: M
authors.initials: M
authors.lastname: Mücke
authors.affiliation: Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Bonn, Bonn, Deutschland.
authors.forename: R
authors.initials: R
authors.lastname: Conrad
authors.affiliation: Radiologische Klinik, Universitätsklinikum Bonn, Bonn, Deutschland.
authors.forename: M
authors.initials: M
authors.lastname: Marinova
authors.affiliation: Klinik für Palliativmedizin, Universitätsklinikum Bonn, Bonn, Deutschland.
authors.forename: H
authors.initials: H
authors.lastname: Cuhls
authors.affiliation: Klinik für Palliativmedizin, Uniklinik RWTH Aachen, Aachen, Deutschland.
authors.forename: F
authors.initials: F
authors.lastname: Elsner
authors.affiliation: Klinik für Palliativmedizin, Uniklinik RWTH Aachen, Aachen, Deutschland.
authors.forename: R
authors.initials: R
authors.lastname: Rolke
authors.affiliation: Klinik für Palliativmedizin, Universitätsklinikum Bonn, Bonn, Deutschland.|Zentrum für Palliativmedizin, Malteser Krankenhaus Seliger Gerhard Bonn/Rhein-Sieg, Bonn, Deutschland.
authors.forename: L
authors.initials: L
authors.lastname: Radbruch
mesh_terms: D000278:Administration, Buccal; D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000072716:Cancer Pain / Q000188:drug therapy*; D059350:Chronic Pain / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects; D010147:Pain Measurement; D010166:Palliative Care / Q000379:methods*
chemical_list: D009020:Morphine; D005283:Fentanyl
keywords: Drug administration schedule; Drug dose-response relationship; Opioid analgesics; Pain measurement; Palliative care