The Effect of a Combination of Diclofenac and Methadone Applied as Gel in a Human Experimental Pain Model - A Randomized, Placebo-controlled Trial

Basic & Clinical Pharmacology & Toxicology
Isabelle M LarsenAnne E Olesen

Abstract

Pain involves responses in which both peripheral and central mechanisms contribute to the generation of pain. Pre-clinical laboratory data have supported that a topical formulation of combined diclofenac and methadone (Diclometh) may alleviate local pain, and potentially, the side effect profile should be low. We hypothesized that antiallodynic and antihyperalgesic effects of Diclometh could be demonstrated in a human experimental pain model and that Diclometh would be safe to administer. Thus, the aims were as follows: (i) to compare two doses of Diclometh versus placebo; and (ii) to assess the safety profile of Diclometh. The study was a crossover, randomized, double-blind, placebo-controlled comparison of two doses of Diclometh gel (0.1% and 0.2%) administered topically in healthy participants. Nerve growth factor (NGF) and capsaicin intradermal injections were used as human pain models. Pressure stimulation, contact heat stimulation, hyperalgesia (pinprick stimulation) and allodynia (brush stimulation) to mechanical stimulation were performed in the area where capsaicin and NGF were injected. Side effects were recorded on a four-point Likert scale. Twenty-one men completed the study (mean age 26.14 ± 5.3). Diclometh 0.2% re...Continue Reading

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Citations

Mar 15, 2020·Journal of Leukocyte Biology·Marwan HassaniNienke Vrisekoop
Jan 31, 2020·Frontiers in Human Neuroscience·Lukas D LindeJohn L K Kramer
Mar 25, 2021·European Journal of Pain : EJP·Charles QuesadaLuis Garcia-Larrea

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