Oral transmucosal fentanyl citrate versus immediate release morphine in the initial dose finding of transdermal fentanyl treatment
Elsner, Frank, Department of Palliative Medicine, University of Aachen, Germany, Eimer, Sebastian, Department of Anesthesiology, University of Cologne, Germany, Sabatowski, Rainer, Department of Anesthesiology, University of Cologne, Germany, Radbruch, Lukas, Department of Anesthesiology, University of Cologne, Germany, Department of Palliative Medicine, University of Aachen, German |
Introduction: Oral transmucosal fentanyl citrate (OTFC) is licensed for breakthrough pain and represents a supplement as rescue medication for transdermal fentanyl (TF). In an open randomised study we compared OTFC with immediate release morphine (IRM) for dose finding of TF treatment.
Methods: Patients with chronic pain who needed a treatment with opioids (WHO III) were included. After randomisation dose titration was performed either by OTFC 200 mg or IRM 10 mg maximum every 30 min. The Brief Pain Inventory (BPI) and the quality-of-life questionnaire SF-12 were used for documentation.
Results: Totally 54 patients with cancer (33) and non-cancer pain (19) were included (OTFC 26; IRM 28). The groups did not differ in pain intensity in BPI (OTFC: NRS 6.2 ± 2.0; IRM: NRS 5.9 ± 1.9) and pain related impairment (OTFC: NRS 5.8 ± 2.1; IRM: NRS 5.2 ± 1.9). They differed in the physical component summary (OTFC: 28.2 ± 7.7; IRM 22.6 ± 3.4; p = 0.039) and the mental component summary (OTFC: 27.1 ± 7.1; IRM 34.1 ± 5.8; p = 0.021) in SF-12. On average 6.7 ± 3.4 titration doses were necassary in the OTFC-group resp. 8.19/4.1 in the IRM-group. Time until pain relief was shorter with OTFC (18.1 ± 5.4 min) than IRM (30.3 ± 7.9 min; p = 0.001). In the OTFC-group 12 pat. dropped out, in the IRM-group there were 7 pat. not finishing the study.
Conclusions: In this study OTFC led to faster pain relief than IRM. The higher number of drop-outs in the OTFC group may be related to a higher number of units than recommended by the manufacturer of OTFC (Actiq†) which may lead to problems with the oral mucosa. Dose titration can be performed both with OTFC and IRM successfully within 24 hours.
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