Safety of Tramadol in Breastfeeding

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In this study we wish to find out how much of the pain relieving drug tramadol, given to women after caesarean section, passes into breast milk. The information will be used to inform lactating women about the risk versus benefit of taking tramadol during early breast feeding. Tramadol has been used overseas for many years but only became available in Australia in 1998. It is now widely used in the treatment of many types of pain and is particularly useful after surgery. There is very little information about the transfer of tramadol and its break-down products into breast milk. One study looking at a single dose of tramadol suggests single doses are unlikely to be a problem, but there is not enough information to be certain about the safety of tramadol for new-born babies when mothers who are breast feeding are taking repeated doses. If the infant was affected in any way this would probabvly be seen as sleepiness, floppiness and poor feeding. We aim to obtain iformation about how much tramadol passes to the breast feeding infant and be able to advise about the likelihood of significant adverse effects. 75 women taking oral tramadol regularly (100 mg every 6 hours)for postoperative pain control will be recruited after removal of their patient controlled epidural analgesia device, usually on day 3 post caesarean section. Breast milk samples will be taken just before the fourth dose and in between the 4th and 5th doses along with a single blood sample. The milk and blood sample will be sent to the laboratory to measure the amount of tramadol and its break-down product. The baby will also be assessed afte the 4th dose for tone and alertness.

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