Table 2.
Approved analgesics for use in the pediatric population in Germany and the US
| Analgesics | Minimum age Germanya | Minimum age USb |
|---|---|---|
| Morphinec | Neonates | Not approved96 |
| Hydromorphone | 1 year | Not approved97 |
| Fentanyl | 2 years | 2 years98,99 |
| Oxycodone | 12 years | 11 years100 |
| Tapentadol | 2 years | Not approved |
| Tramadol | 1 year | d12 years95 |
| Metamizole | 3 months | Not approved93 |
| Paracetamol | Term neonates | Neonates101 |
| Ibuprofen | 3 months | 6 months102 |
| Diclofenac | 6 years | Not approved103 |
| Aspirin | 12 years | Not approved104 |
| Combination products | ||
| Codeine/paracetamol | 12 years | d12 years94 |
| Dihydrocodeine/aspirin/caffeine | Not available | d12 years105 |
| Butalbital/paracetamol/caffeine | Not available | 12 years106 |
Notes: Data presented as a poster at 7th Congress of the European Academy of Paediatric Societies (EAPS 2018) Paris, France, October 30–November 3, 2018.91 aAnalgesics commonly used in the pediatric population and their approved age ranges for use in Germany. Data from the German Summaries of Medicinal Product Characteristics (SMPCs) obtained from www.rote-liste.de.107 Only analgesics for systemic use were analyzed. bAnalgesics commonly used in the pediatric population and their approved age ranges for use in the US. Data from FDA webpage92 and individual SPCs of the analgesics. cspecial precautions to be taken for infants below 1 year; dspecial precautions to be taken for children and adolescents below 18 years.