PURPOSE: The objective of the present prospective study was to compare the safety and efficacy of a 12-h method to a 6-h method in chronic cancer pain management. MATERIALS AND METHODS: Randomized, prospective clinical trial was conducted between December 2007 and June 2009, enrolling 90 patients with chronic cancer pain. Patients with chronic cancer pain were randomly assigned to the conversion from continuous intravenous infusion to transdermal fentanyl using two-step taper of the continuous intravenous infusion in 12 h (12-h method) or the conversion in 6 h (6-h method). The parameters assessed in the present study included pain intensity (on a scale of 0 to 10) and bolus use frequency, and the adverse effects were assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 3. RESULTS:Pain intensity and the number of boluses during conversion remained stable in both arms. The incidence of adverse events was 25.6% in the 12-h method group and 2.3% in the 6-h method group (95% confidence interval, 0.01-0.55; p = 0.002). Adverse events occurred in four patients at 6-12 h, five patients at 12-18 h, two patients at 18-24 h, and one patient at 24-48 h after application. CONCLUSIONS: Excellent safety profile and sustained efficacy are shown for the 6-h conversion method.
RCT Entities:
PURPOSE: The objective of the present prospective study was to compare the safety and efficacy of a 12-h method to a 6-h method in chronic cancer pain management. MATERIALS AND METHODS: Randomized, prospective clinical trial was conducted between December 2007 and June 2009, enrolling 90 patients with chronic cancer pain. Patients with chronic cancer pain were randomly assigned to the conversion from continuous intravenous infusion to transdermal fentanyl using two-step taper of the continuous intravenous infusion in 12 h (12-h method) or the conversion in 6 h (6-h method). The parameters assessed in the present study included pain intensity (on a scale of 0 to 10) and bolus use frequency, and the adverse effects were assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 3. RESULTS:Pain intensity and the number of boluses during conversion remained stable in both arms. The incidence of adverse events was 25.6% in the 12-h method group and 2.3% in the 6-h method group (95% confidence interval, 0.01-0.55; p = 0.002). Adverse events occurred in four patients at 6-12 h, five patients at 12-18 h, two patients at 18-24 h, and one patient at 24-48 h after application. CONCLUSIONS: Excellent safety profile and sustained efficacy are shown for the 6-h conversion method.
Authors: Angela W Miser; Prem K Narang; Judith A Dothage; Robert C Young; William Sindelar; James S Miser Journal: Pain Date: 1989-04 Impact factor: 6.961
Authors: A N Sandler; A D Baxter; J Katz; B Samson; M Friedlander; P Norman; G Koren; S Roger; K Hull; J Klein Journal: Anesthesiology Date: 1994-11 Impact factor: 7.892
Authors: Detlev F J Zech; Stefan U A Grond; John Lynch; Hans G Dauer; Bernd Stollenwerk; Klaus A Lehmann Journal: Pain Date: 1992-09 Impact factor: 6.961
Authors: Astrid W Oosten; João A Abrantes; Siv Jönsson; Peter de Bruijn; Evelien J M Kuip; Amílcar Falcão; Carin C D van der Rijt; Ron H J Mathijssen Journal: Eur J Clin Pharmacol Date: 2016-01-14 Impact factor: 2.953