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• W2040987022 abstract "We read with interest the recent article by Navigante et al. concerning the use of midazolam as adjunct therapy to morphine for palliation of dyspnea in advanced cancer patients with life expectancy of less than a week.1Navigante A. Cerchietti L. Midazolam as adjunct therapy to morphine in the alleviation of severe dyspnea perception in patients with advanced cancer.J Pain Symptom Manage. 2006; 31: 38-47Abstract Full Text Full Text PDF PubMed Scopus (166) Google Scholar In their prospective study, 101 patients were randomly assigned to one of three arms to receive around-the-clock morphine with midazolam rescue doses in case of breakthrough dyspnea (BD), around-the-clock midazolam with morphine rescue doses in case of BD, or around-the-clock midazolam plus morphine with morphine rescue doses in case of BD. All drugs were given by subcutaneous injection for a period of 48 hours after randomization. None of the patients received oxygen therapy during the study. Nearly 30% of patients in each arm died during the study, probably due to disease progression; there was no time relation between death and drug administration. The authors conclude that the beneficial effects of morphine in controlling baseline levels of dyspnea could be improved by the addition of midazolam to the treatment. We agree with authors about the importance of treating the anxiety associated with basal dyspnea and the episodes of BD, but some methodological issues should be raised. Firstly, oxygen saturation data were reported only for baseline and at 24 and 48 hours after randomization: no information is given about the timing relationship between oxygen saturation possible worsening or death and drug administrations. Secondly, even though nearly 30% of patients died in each arm during the study, it is not detailed if the reported percentage of patients who experienced a relief in their dyspnea after 48 hours was assessed on the whole number of patients randomized rather than on the number of patients alive at the end of this period. The lack of oxygen administration raises some ethical concerns, too: Could we consider as ethically acceptable a clinical trial where palliative oxygen administration is not offered to patients with a median peripheral SO2 of about 70%? The literature concerning this matter suggests that, at least, a short trial with palliative oxygen is often indicated.2Bruera E. De Stoutz N. The effects of oxygen on the intensity of dyspnea in hypoxemic terminal cancer patients.Lancet. 1993; 342: 13-14Abstract PubMed Scopus (187) Google Scholar, 3Bruera E. Schoeller T. MacEachern T. Symptomatic benefit of supplemental oxygen in hypoxemic patients with terminal cancer: the use of the N of 1 randomized trial.J Pain Symptom Manage. 1992; 7: 365-368Abstract Full Text PDF PubMed Scopus (88) Google Scholar, 4Bruera E. A randomized controlled trial of supplemental oxygen versus air in cancer patients with dyspnea.Palliat Med. 2003; 17: 659-663PubMed Google Scholar Third, we wonder why the authors chose bolus drug administration, instead of continuing IV/SC infusion, which may possibly reduce the risk of respiratory depression due to plasma peaks of drugs and avoid painful injections. Finally, we think that a control arm in which patients receive morphine either for basal dyspnea or BD could have represented a more complete comparison, if we consider the current literature and clinical practice. Moreover, the observation time of the study is limited to 48 hours, so we do not have any information about the clinical evolution of patients after the end of the observation period. This could have been useful to understand whether the clinical criteria used to prospectively select the patients were correct and to exclude late side effects related to the treatment. A recent editorial published in the Journal of Clinical Oncology underlines the difficulties in conducting prospective studies in the palliative care setting: Prospectively identifying terminal patients and collecting a representative sample are a complex art, as is obtaining information from very ill patients.5Earle C. Looking back from death: the value of retrospective studies of end-of-life care.J Clin Oncol. 2006; 24: 838-840Crossref PubMed Scopus (97) Google Scholar Furthermore, ethical bonds make it a challenge to plan prospective studies of end-of-life care. For these reasons, we deeply appreciate the efforts of Navigante et al. in conducting this complex trial, despite some limitations." @default.
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• W2040987022 date "2007-03-01" @default.
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• W2040987022 title "Midazolam as Adjunct Therapy to Morphine to Relieve Dyspnea?" @default.
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• W2040987022 doi "https://doi.org/10.1016/j.jpainsymman.2006.12.001" @default.
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