Liver, Renal, and Cardiovascular Failure After Unintentional Overdose of Tizanidine in a 2-Year-Old Child.

Tizanidine is a central alpha-2 adrenergic receptor agonist indicated for the treatment of spasticity in adults; however, its use in the pediatric population is considered off-label. In adults, the dose is gradually titrated until the desired reduction in muscle tone is achieved. Hypotension is a frequent adverse effect, but impaired liver function is not characteristic of alpha-2 adrenergic agonist overdose.

The DEC-net European register of paediatric drug therapy trials: contents and context.

Objective: To describe the results and conclusions of DEC-net, an international, publicly available register of paediatric drug therapy clinical trials, and to assess which paediatric health areas are covered by research and by which trial types.

Methods: The contents of the register, which was set up by four groups (Italy, UK, France, Spain) who searched for paediatric trials and collected data between 2004-2006, were analysed. The disease areas reflected were compared with those covered by published trials and Burden of Disease (BD) data.

[A complete clinical trial register is already a reality in the paediatric field].

Clinical trials have a fundamental role in promoting an evidence based use of drugs in adults and in children. However, it is often difficult to identify the few paediatric studies carried out and to thus implement knowledge derived from them. Furthermore, studies that are stopped prematurely or that have insignificant or negative results often remain unpublished, leading to duplication of effort by researchers, waste of resources and concealment of potentially toxic risks.