Pain management in the paediatric population: the regulatory situation in Europe

Abstract

This study compared the availability and the licensing status of analgesic drugs marketed in three European countries (Italy, France and the UK) and evaluated the evidence on safety and efficacy in the paediatric population of the drugs reported in the European Medicines Evaluation (EMA) document "Assessment of Pediatric Needs: Pain" (2005). Ten of 17 drugs reported in the EMA document were marketed with a paediatric licence in all three countries but with wide differences concerning age groups. In all, 594 randomised controlled trials (RCTs) concerning the 17 drugs in the EMA list were found through biomedical literature databases. Bupivacaine was the drug with the most trials retrieved (171 RCTs, 29%); 32 (5%) RCTs concerned clonidine not licensed for pain control, and 51 (9%) concerned ketamine licensed for paediatric use only in the UK. Access to, and the rational use, of drugs to prevent or control pain and its functional consequences pose a considerable challenge. There is a pressing need for further research and clinical development in the assessment and management of pain in children.

Safety Issues of Pharmacological Acute Pain Treatment in Children

“…Overall, commonly used agents worldwide include morphine, oxycodone, hydromorphone, fentanyl, and tramadol with variable licensing status from one country to another. 70 Codeine, and tramadol in some countries, is now contraindicated in children due to the risk of fatal ADRs linked to the variable activity of CYP2D6 even at therapeutic dosing. 71,72 Opioid PK properties vary according to the molecule considered.…”