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Title: Importance trial: A provisional study-design of a singlecenter, phase II, double-blinded, placebo-controlled, randomized, 4-week study to compare the efficacy and safety of intranasal esketamine in chronic opioid refractory pain
Autores: Fernandes, M.
Schelotto, M.
Doldi, P. M.
Milani, G.
Manzano, A. A.
Perera Valdivia, D.
Winter Matos, Alexandra Marie
Hamdy Abdelrahim, Y.
Hamad Bek, S. A.
Benítez, B. K.
Romanelli Tavares, V. L.
Basendwah, A. M.
Albuquerque Sousa, L. H.
Faria Xavier, N.
Zertuche Maldonado, T.
Toyomi de Oliveira, S.
Chaker, M.
Menon Miyake, M.
Uygur Kucukseymen, E.
Waqar, K.
Alkhozondar, O. M. J.
Bernardo da Silva, R.
Droppelmann, G.
Vaz de Macedo, A.
Nakamura, R.
Fregni, F.
Researchers (UNIBE): Winter Matos, Alexandra Marie 
Affiliations: Facultad de Ciencias de la Salud 
Research area: Ciencias de la Salud
Keywords: Cancer pain; Esketamine; Pain measurement; Opioid refractory
Issue Date: 2021
Publisher: F1000 Research Ltd
Source: F1000Research, 10(42)
Journal: F1000 Research 
Volume: 10
Issue: 42
Background: Cancer is the second leading cause of death globally. Up to 86% of advanced cancer patients experience significant pain, while 10-20% live in chronic pain. Besides, increasing prescription of opioids resulted in 33,000 deaths in the US in 2015. Both reduce patients’ functional status and quality of life. While cancer survival rates are increasing, therapeutic options for chronic opioid refractory pain are still limited. Esketamine is the s-enantiomer of ketamine, with superior analgesic effect and less psychotomimetic side effects. Intranasal esketamine was approved by the FDA for treatment-resistant depression. However, its use in chronic cancer pain has never been tested. Therefore, we propose a phase II, randomized, placebo-controlled trial to evaluate the efficacy and safety of intranasal esketamine in chronic opioid refractory cancer pain.
Methods and analysis: We will recruit 120 subjects with chronic opioid refractory pain, defined as pain lasting more than 3 months despite optimal therapy with high dose opioids (>60 mg morphine equivalent dose/day) and optimal adjuvant therapy. Subjects will be randomized into two groups: intranasal esketamine (56mg) and placebo. Treatment will be administered twice a week for four consecutive weeks. The primary outcome is defined as reduction in the Numeric Pain Rating Scale (NPRS) after first application. Secondary outcomes include NPRS reduction after four weeks, the number of daily morphine rescue doses, functional status and satisfaction, and depression. Conclusion: This study may extend therapeutic options in patients with chronic pain, thus improving their quality of life and reducing opioid use.
This study protocol was developed within the Principles and Practice in Clinical Research (PPCR) Course of Harvard T.H. Chan School of Public Health. Professor of Epidemiology at Harvard T.H. Chan School of Public Health: Felipe Fregni, MD, PhD, MMSc, MPH, Med.
DOI: 10.12688/f1000research.27809.1
Appears in Collections:Publicaciones del Área de Salud - Medicina
Publicaciones indexadas en Scopus / Web of Science

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