| A randomized, double-blind, double-dummy, crossover trial comparing the safety and efficacy of oral sustained-release hydromorphone with immediate-release hydromorphone in patients with cancer pain. Canadian Palliative Care Clinical Trials Group. | |
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MedLine Citation:
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PMID: 8622092 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To evaluate the safety and efficacy of a new slow-release preparation of hydromorphone (SRH) in the treatment of cancer pain. PATIENTS AND METHODS: Ninety-five adult patients from three Canadian Palliative Care Centers with no evidence of mental impairment received treatment for cancer pain with an oral opioid analgesic. After informed consent was obtained, patients underwent titration to a stable dose of immediate-release hydromorphone (IRH) for 48 hours, and were then randomized to receive IRH or SRH for 5 days in a double-blind basis. During day 6, a crossover took place, and patients received the alternate drug for 5 days. Pain intensity was assessed using a visual analog scale (VAS) and ordinal scale (OS). Side effects were assessed using VAS. Patients and investigators made a blinded global rating of efficacy a blinded final choice between SRH and IRH. RESULTS: In 75 assessable patients, pain intensity of the VAS and OS were (mean +/- SD) 27 +/- 21 and 1.3 +/- 0.6 on IRH, versus 29 +/- 21 (P = .13) and 1.3 +/- 0.6 (P = .19) on SRH, respectively. The total number of extra doses of opioids, global rating, and final blinded choice by both patients and investigators were not significantly different between IRH and SRH. Differences in side effects were not significant. CONCLUSION: Our findings suggest that SRH is as safe and effective as IRH in the treatment of cancer pain. |
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Authors:
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E Bruera; P Sloan; B Mount; J Scott; M Suarez-Almazor |
Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology Volume: 14 ISSN: 0732-183X ISO Abbreviation: J. Clin. Oncol. Publication Date: 1996 May |
Date Detail:
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Created Date: 1996-06-18 Completed Date: 1996-06-18 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8309333 Medline TA: J Clin Oncol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 1713-7 Citation Subset: IM |
Affiliation:
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Division of Palliative Care Medicine, University of Alberta, Edmonton, Canada. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Canada Cross-Over Studies Delayed-Action Preparations Double-Blind Method Female Humans Hydromorphone / administration & dosage*, adverse effects Male Middle Aged Neoplasms / complications* Pain / drug therapy*, etiology Pain Measurement Palliative Care* |
| Chemical | |
Reg. No./Substance:
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0/Delayed-Action Preparations; 466-99-9/Hydromorphone |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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