Scientific article
OA Policy
English

Validation of the simplified UVB model to assess the pharmacodynamics of analgesics in healthy human volunteers

Published inChimia, vol. 66, no. 5, p. 296-299
Publication date2012
Abstract

A pharmacokinetic/pharmacodynamic, randomized, crossover, placebo-controlled study was conducted in healthy human volunteers with the primary objective of exploring the existence of a positive interaction between paracetamol 1 g and ketorolac 20 mg intravenously on experimental pain models. Further, the simplified UVB model was validated as a screening tool for analgesics or a combination of analgesics in clinical drug development. It was observed that the UVB irradiation induced primary hyperalgesia, evidenced by significant decreases of the heat pain threshold from (mean ± SD) 46.9 ± 1.1 °C to 40.1 ± 1.7 °C (p <0.001) and of the mechanical pain threshold (62% decrease). A small intra- and inter-individual variability was observed as well as consistent intra-day stability for the heat pain threshold. The UVB irradiation also resulted in the development of an area of secondary hyperalgesia of 21.3 ± 11.3 cm(2). The mechanical pain threshold and area of secondary hyperalgesia showed small intra-individual variability and consistent intra-day stability. However, a greater variability was observed between subjects, which suggests that a crossover design would allow limiting the number of subjects.

Keywords
  • Acetaminophen/pharmacokinetics/therapeutic use
  • Adult
  • Analgesics/pharmacokinetics/therapeutic use
  • Analgesics, Non-Narcotic/pharmacokinetics/therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal/pharmacokinetics/therapeutic use
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Combinations
  • Feasibility Studies
  • Humans
  • Hyperalgesia/drug therapy
  • Injections, Intravenous
  • Ketorolac/pharmacokinetics/therapeutic use
  • Male
  • Middle Aged
  • Models, Biological
  • Pain Measurement
  • Pain Threshold/drug effects
  • Sunburn/drug therapy/metabolism
  • Ultraviolet Rays/adverse effects
  • Young Adult
Citation (ISO format)
ING LORENZINI, Kuntheavy et al. Validation of the simplified UVB model to assess the pharmacodynamics of analgesics in healthy human volunteers. In: Chimia, 2012, vol. 66, n° 5, p. 296–299. doi: 10.2533/chimia.2012.296
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Article (Published version)
accessLevelPublic
Identifiers
Journal ISSN0009-4293
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