Tramadol oral solution: new drug. Poorly evaluated and potentially dangerous in children.
(1) Codeine, either used alone or in combination with paracetamol, is the standard step-2 opiate analgesic for children from the age of one year. (2) An oral solution of tramadol, another step-2 opiate analgesic, was recently approved in France for the treatment of children at least three years of age. (3) The only clinical trials of tramadol in this age group focused on short-term treatment of postoperative pain. Tramadol has not been compared with codeine, ibuprofen, or correctly dosed paracetamol (step-1 analgesic). Tramadol has been compared with diclofenac, a nonsteroidal antiinflammatory drug, in a trial that included patients over 11 years of age (including adults), but the results of this trial are uninformative because patients were not blinded and no separate paediatric subgroup analysis was carried out. (4) The adverse effects of tramadol in children appear to be mild but frequent (especially vomiting). (5) As with codeine, deaths have been reported following accidental overdose with oral tramadol in children. (6) There is no justification for prescribing such a potentially harmful drug with poorly documented efficacy.
D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003061:Codeine / Q000627:therapeutic use; D017277:Drug Approval; D005602:France; D006801:Humans; D010149:Postoperative Pain / Q000188:drug therapy; D014147:Tramadol / Q000008:administration & dosage / Q000009:adverse effects / Q000506:poisoning / Q000627:therapeutic use*; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D014147:Tramadol; D003061:Codeine