IMPORTANCE trial: a provisional study-design of a single-center, phase II, double-blinded, placebo-controlled, randomized, 4-week study to compare the efficacy and safety of intranasal esketamine in chronic opioid refractory pain

• DOI: 10.12688/f1000research.27809.1
• Publication Date: 2021-01-22T15:56:25Z
• Authors: Mauricio Fernandes; Magdalena Schelotto; Philipp Maximilia...; Giovanna Milani; Abul Andrés Ariza...; Doriam Perera Val...; Alexandra Marie W...; Yasmin Hamdy Abde...; Shaza Ahmed Hamad...; Benito K. Benitez; Vanessa Luiza Rom...; Abdulrahim M. Bas...; Luis Henrique Alb...; Naiara Faria Xavier; Tania Zertuche Ma...; Sarah Toyomi de O...; Melisa Chaker; Michelle Menon Mi...; Elif Uygur Kucuks...; Kinza Waqar; Ola M.J. Alkhozondar; Ricardo Bernardo ...; Guilhermo Droppel...; Antonio Vaz de Ma...; Rui Nakamura; Felipe Fregni
• Keywords: Pain, Intractable; 3. Good health; Analgesics, Opioid; Study Protocol; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Double-Blind Method; Quality of Life; Humans; Ketamine; Chronic Pain

<ns3:p><ns3:bold>Background:</ns3:bold> Cancer is the second leading cause of death globally. Up to 86% advanced cancer patients experience significant pain, while 10-20% live in chronic pain. Besides, increasing prescription opioids resulted 33,000 deaths US 2015. Both reduce patients’ functional status and quality life. While survival rates are increasing, therapeutic options for opioid refractory pain still limited. Esketamine s-enantiomer ketamine, with superior analgesic effect less psychotomimetic side effects. Intranasal esketamine was approved by FDA treatment-resistant depression. However, its use has never been tested. Therefore, we propose a phase II, randomized, placebo-controlled trial evaluate efficacy safety intranasal pain.</ns3:p><ns3:p> <ns3:bold>Methods analysis:</ns3:bold> We will recruit 120 subjects defined as lasting more than 3 months despite optimal therapy high dose (&gt;60 mg morphine equivalent dose/day) adjuvant therapy. Subjects be randomized into two groups: (56mg) placebo. Treatment administered twice week four consecutive weeks. The primary outcome reduction Numeric Pain Rating Scale (NPRS) after first application. Secondary outcomes include NPRS weeks, number daily rescue doses, satisfaction, depression.</ns3:p><ns3:p> <ns3:bold>Conclusion:</ns3:bold> This study may extend thus improving their life reducing use.</ns3:p><ns3:p> <ns3:bold>Trial registration:</ns3:bold> Clinical Trials.gov, <ns3:ext-link xmlns:ns4="http://www.w3.org/1999/xlink" ext-link-type="uri" ns4:href="https://clinicaltrials.gov/ct2/show/NCT04666623">NCT04666623</ns3:ext-link>. Registered on 14 December 2020</ns3:p>