NEOOPIOID

No Pain during infancy by adapting off-patent medicines

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 Obiettivo del progetto (Objective)

'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.'

Introduzione (Teaser)

Infants have the right to alleviation of pain in the same individualised way as adult patients. Based on this notion, a European study explored the efficacy and side-effects of common analgesic drugs used to treat newborn babies.

Descrizione progetto (Article)

Newborn babies admitted to neonatal intensive care units (NICUs) may require medical treatments and painful procedures which often cause prolonged pain. It is now well established that infants reach pain to a conscious level and also exhibit physiological and behavioural responses to pain.

Current management of neonatal pain is far from optimal and is usually given in less than 30 % of cases undergoing painful procedures. Emerging experimental evidence indicates that prolonged pain in the neonatal period may lead to cognitive, behavioural and neurodevelopmental outcomes.

The most common analgesic treatment entails the use of morphine and fentanyl. However, their long-term safety has not been extensively explored.

Based on this, scientists on the EU-funded 'No pain during infancy by adapting off-patent medicines' (http://www.neoopioid.eu (NEOOPIOID)) project evaluated the impact and safety of opioid treatment in preterm and full term newborn infants. The goal was to develop more personalised sedative/analgetic (S/A) drug therapy for neonates.

The NEOOPIOID consortium performed a questionnaire-based study with about 6 700 participating patients from 18 EU countries. Results showed that most centres used either morphine or fentanyl without practicing any kind of pain assessment of ventilated neonates.

To test the safety and efficacy of analgesic drugs, researchers performed a clinical trial where pain levels were evaluated using an optimised scoring system. Particular emphasis was given to the impact of these drugs on the neonatal brain.

Blood taken from newborn babies was analysed by specialised methods for the presence of opioids and their metabolites.

This helped to study the pharmacokinetic and pharmacogenomic properties of morphine and fentanyl and implement the appropriate dosage according to developmental stage.

The study concluded that bolus rather than continuous administration of S/A drugs should be given to infants. Researchers were also interested in the relation between polymorphisms in candidate genes (COMT, KCNJ6) and the pain relieving effect of analgesic drugs.

Overall, the NEOOPIOID study provided recommendations on how to assess and treat neonatal pain with S/A drugs. Given the increasing number of preterm births in Europe, more and more infants get exposed to opioid treatment or to suboptimal pain relief. Implementation of the project findings for a better use of analgesics is expected to improve care of newborn infants.