Flavia Karine Rigo1, Gabriela Trevisan2, Maria C Godoy3, Mateus Fortes Rossato4, Gerusa D Dalmolin5, Mariane A Silva6, Mirian S Menezes3, Wolnei Caumo7, Juliano Ferreira5. 1. Graduation Core of Santa Casa de Belo Horizonte, Department of Biomedicin and Medicin, Belo Horizonte, MG, Brazil; Department of Health, University of South of Santa Catarina - UNESC, Criciuma - SC, Brazil. 2. Department of Health, University of South of Santa Catarina - UNESC, Criciuma - SC, Brazil. 3. Department of Surgery and Anesthesia, Center of Health Science, University Hospital of Santa Maria, Federal University of Santa Maria, RS, Brazil. 4. Center of Innovation and Preclinical Studies - CIEnP, Florianopolis - SC, Brazil. 5. Department of Pharmacology, Federal University of Santa Caratina, Florianopolis - SC, Brazil. 6. Departament of Health, Course of Biomedicine University of Education and Culture of Vilhena, Vilhena, RO, Brazil. 7. Service of pain and palliative care and pain and Neuromodulation Laboratory, Hospital de Clinicas de Porto Alegre, Brazil.
Abstract
BACKGROUND:Methadone and ketamine are used in neuropathic pain management. However, the benefits of both drugs association are uncertain in the treatment of neuropathic pain. OBJECTIVE: Our primary objective was test the hypothesis that oral methadone combined with oral ketamine is more effective than oral methadone or ketamine alone in reducing neuropathic pain. STUDY DESIGN: We conducted a randomized, double blind, active-controlled parallel-group clinical trial. METHODS:Forty-two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive oral methadone (n = 14), ketamine (n = 14), or methadone plus ketamine (n = 14) over a 3-month period. RESULTS: During these 90 days, we observed pain scores using a visual analogical scale (VAS), allodynia, burning/shooting pain, and some side effects. All treatments were effective in reducing pain scores by at least 40%. However, a significant improvement in pain was observed only in the ketamine alone group compared with both the methadone or methadone/ketamine groups. No significant differences were observed among the treatment groups for the reduction of burning or shooting pain, while ketamine alone was more effective than methadone or methadone/ketamine for the reduction of allodynia. LIMITATIONS: Formal assessment for awareness of the allocation was not performed, some co-intervention bias may have occurred, our results could be only relevant to the patient population investigated and the use of VAS as the primary outcome detect changes in pain intensity but not to assess neuropathic pain symptoms. CONCLUSION: This study indicates that ketamine was better than methadone or methadone/ketamine for treating neuropathic pain.Key words: Multimodal analgesia, refractory pain, NMDA receptor, opioid.
RCT Entities:
BACKGROUND:Methadone and ketamine are used in neuropathic pain management. However, the benefits of both drugs association are uncertain in the treatment of neuropathic pain. OBJECTIVE: Our primary objective was test the hypothesis that oral methadone combined with oral ketamine is more effective than oral methadone or ketamine alone in reducing neuropathic pain. STUDY DESIGN: We conducted a randomized, double blind, active-controlled parallel-group clinical trial. METHODS: Forty-two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive oral methadone (n = 14), ketamine (n = 14), or methadone plus ketamine (n = 14) over a 3-month period. RESULTS: During these 90 days, we observed pain scores using a visual analogical scale (VAS), allodynia, burning/shooting pain, and some side effects. All treatments were effective in reducing pain scores by at least 40%. However, a significant improvement in pain was observed only in the ketamine alone group compared with both the methadone or methadone/ketamine groups. No significant differences were observed among the treatment groups for the reduction of burning or shooting pain, while ketamine alone was more effective than methadone or methadone/ketamine for the reduction of allodynia. LIMITATIONS: Formal assessment for awareness of the allocation was not performed, some co-intervention bias may have occurred, our results could be only relevant to the patient population investigated and the use of VAS as the primary outcome detect changes in pain intensity but not to assess neuropathic pain symptoms. CONCLUSION: This study indicates that ketamine was better than methadone or methadone/ketamine for treating neuropathic pain.Key words: Multimodal analgesia, refractory pain, NMDA receptor, opioid.
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