Professor Adriana Ceci from Fondazione Gianni Benzi, cooperated as co-author to the article “Dose rationale for gabapentin and tramadol in pediatric patients with chronic pain” just published in the Pharmacology Research & Perspectives journal.
The work, developed within the Gabapentin in Pediatric Pain (GAPP) Consortium, illustrates the use of clinical trial simulations as a tool for optimizing doses and protocol design for a prospective investigation in paediatric patients with chronic pain. Particularly, pharmacokinetic modeling and clinical trial simulations were used to describe the pharmacokinetic of gabapentin and tramadol in children.
Despite off-label use, the efficacy and safety of gabapentin and tramadol in paediatric patients with chronic pain has not been characterized. However, generating evidence based on randomized clinical trials in this population has been extremely challenging. Numerous issues with paediatric study protocols, including small sample size, lack of clear details on dose adjustment, age and ethics issues occur.
Authors emphasize that pharmacokinetic modelling, extrapolation and simulation can overcome some of these challenges enabling the implementation of a robust, informative clinical trial protocol and of the dose rationale for gabapentin and tramadol in children.
Read the full article here!
This investigation was supported by the Gabapentin in Pediatric Pain (GAPP) Consortium, which has received funding from the European Union's Seventh Framework Programme for research technological development, and demonstration under grant agreement n° 602962.