drugset / Trial / NCT02303886

Methylene Blue Intravenously and Chronic Neuropathic Pain

NCT02303886

Completed 10 enrolled Uppsala University
RandomizedCrossoverDouble-blindTreatment

Summary

Aim of Investigation Methylene blue (MB) is a diaminophenothiazine with antioxidant, anti-inflammatory properties and with inhibitory effects on nitric oxide. The aim of this study was to determine the clinical effectiveness of MB in the treatment of neuropathic pain. Methods Ten patients with neuropathic pain were randomized to receive one of the two treatments: methylene blue (MB1) 2 mg/kg (10 mg/mL Methyltioninklorid, Apoteket, Umeå, Sweden) or methylene blue (MB2) 0.02 mg/kg. Both MB solutions were infused intravenously over 60 minutes. The sensory function and the pain were evaluated at baseline and at 60 min after the start of infusions. A pain journal was kept by the patients in the following 5 days. Plasma and urinary concentrations of 8-isoprostane-prostaglandin F2α (8-iso-PGF2α) an indicator of oxidative injury, were measured with radioimmunoassay (RIA). A panel of 92 proteins biomarkers were determined with Proximity Extension Assay (PEA) prior and after infusions. comparison with the control group. MB infusion produced an enhancement of prolactin.

Timeline

Start
2009-03
Primary completion
2012-06
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylene Blue Diagnostic / imaging agent 0.02 mg/kg Intravenous
Comparator Methylene Blue Diagnostic / imaging agent 2 mg/kg Intravenous

Indications