NEOOPIOID · No Pain during infancy by adapting off-patent medicines

Preterm and newborn infant may suffer from pain in the same way as adults. They are even more sensitive to pain due to immaturity of endogenous modulation. Thus, they should have the same human right to be alleviated from pain. The overall aim of this project is to assess effects and safety of opioid treatment in very preterm up to full term newborn infants in relation to pharmacokinetics predisposition. Furthermore, a major goal is to develop a PUMA for safe administration of opioid analgesic treatment in newborn infant. Both morphine and fentanyl are off-labelled (EMEA) drugs. Several studies have shown that opioid treatment in newborn reduce pain and stress responses. However, these drugs also have side-effects related to plasma concentrations of the drugs and their metabolites. The new approach in the current project is to obtain a more personalized drug therapy to the newborn infant, and to consider individual differences in pharmacokinetics, as well as gender effects. We will perform a multinational European survey of practices regarding sedation and analgesia in neonatal units. Clinical multicenter trial evaluating safety aspects of morphine and fentanyl will be performed. The responses (evaluated with validated pain scales) will be related to pharmacokinetics predisposition. A ”child friendly” formulation adapted for use in neonates will be developed by the SME partner in the NeoOpioid project. The results will be disseminated by scientific and popular articles, the web, videos and special pain courses for physicians and nurses etc. The NeoOpioid project will lead to a considerable improvement of the strategy to alleviate newborn pain.