A new article published on 6 October 2023 in the Journal of the British Pharmacological Society titled
“Dose rationale for gabapentin and tramadol in paediatric patients with chronic pain” co-authored by Prof Adriana Ceci and Dr Mariagrazia Felisi, respectively CVBF’s Scientific Advisor and Quality Assurance Head, shedding light on the dearth of substantial evidence regarding the effectiveness and safety of these drugs, currently used off-label, in the management of chronic pain in the paediatric population.

Recognized the challenges in conducting clinical trials in children with chronic pain, including small sample sizes, ethical concerns, and difficulties measuring pain consistently across paediatric age groups, this paper highlights the pivotal role played by pharmacokinetic modelling and simulation tools in streamlining and ensuring a robust dose rationale and protocol for upcoming paediatric trials evaluating gabapentin use for chronic pain.This work is conducted by the Gabapentin in Paediatric Pain (GAPP) Consortium, a European Project coordinated by CVBF that aims to address some of these issues via the implementation of randomized clinical studies and retrospective and prospective pharmacovigilance data collection on the efficacy and safety of gabapentin.

Within the Consortium, ongoing evaluations are in progress to explore the integration of these crucial findings into the development of a new adaptive study design for the assessment of the efficacy and safety of gabapentin in children affected by chronic pain also considering the new pain definition and classification recently released by the International Association for the Study of Pain.

To read the full article, click here.