Gennaio 2016 - Volume XXXV - numero 1
1Dipartimento della Donna, del Bambino e di Chirurgia Generale e Specialistica, Seconda Università di Napoli
2IRCCS Materno-Infantile “Burlo Garofolo”, Trieste
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Key words: Codeine, Pain, Tramadol, Tramadol pharmacodinamic, Tramadol pharmacokinetic
In June 2013, the European Medicine Agency (EMA) prohibited the use of medicines containing codeine for patients under 12 years of age. The EMA recommendations impose a change in the management of moderate-severe pain in children. Tramadol, an opioid-related analgesic with an intermediate analgesic potency between NSAIDs and major opioids, is a possible substitute for codeine in children. It shows less respiratory depression and sedation as well as other adverse effects of opioids and also has no clinically relevant effects on heart rate and blood pressure. It acts like a weak or partial agonist with no affinity for δ e κ opioid receptors and its central analgesic effects are partially reversed by naloxone. According to the available evidence, tramadol appears to be efficacious in the management of moderate-severe pain in children and safe both in inpatients and outpatients with no case of paediatric respiratory depression at therapeutic dosage being currently reported in the literature. Nevertheless, it may be appropriate to limit the use of tramadol to monitored settings for children with specific risk factors (adeno-tonsillectomy, sleep apnoea, obesity, renal impairments and the neonatal period), subject to further safety evidence. This review takes into consideration the available evidence on the pharmacokinetic and pharmacodynamic efficacy and safety profile of tramadol.
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