ArticleBritish journal of clinical pharmacology2008
Use of a sparse sampling study design to assess transfer of tramadol and its O-desmethyl metabolite into transitional breast milk.
Article in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 62 citations in OpenAlex.
- Trial
- Drugs in Human Milk Part 1: Practical and Analytical Considerations in Measuring Drugs and Metabolites in Human Milk.Clinical pharmacokinetics · 2024Review
- Sertraline, citalopram and paroxetine in lactation: passage into breastmilk and infant exposure.Frontiers in pharmacology · 2024Article
- Neonatal Exposure to Tramadol through Mother's Breast Milk.Journal of analytical toxicology · 2021Article
- A Patient-Controlled Intravenous Analgesia With Tramadol Ameliorates Postpartum Depression in High-Risk Woman After Cesarean Section: A Randomized Controlled Trial.Frontiers in medicine · 2021Article
- Development of an improved murine model of necrotizing enterocolitis shows the importance of neutrophils in NEC pathogenesis.Scientific reports · 2020Article
- NEC is likely a NETs dependent process and markers of NETosis are predictive of NEC in mice and humans.Scientific reports · 2018Article
- Drugs in Lactation.Pharmaceutical research · 2018Review
- Changes in milk composition associated with pethidine-PCEA usage after Caesarean section.Maternal & child nutrition · 2017Article
- Pharmacogenomic considerations in opioid analgesia.Pharmacogenomics and personalized medicine · 2012Article
- Population pharmacokinetic modeling of tramadol and its O-desmethyl metabolite in plasma and breast milk.European journal of clinical pharmacology · 2011Article
- Tramadol withdrawal in a neonate: only one of the clinical presentations to be anticipated...European journal of clinical pharmacology · 2009Article
- Prescribing in pregnancy and lactation.British journal of clinical pharmacology · 2008Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
what is already known about this subjectThere are presently no published data on tramadol transfer into breast milk or on its effects in the breastfed infant. WHAT THIS STUDY ADDS: We have provided quantitative data on the absolute and relative infant doses of rac-tramadol and it rac-O-desmethyl metabolite for the breastfed infant. We have also demonstrated a novel sparse sampling data collection method for investigating infant exposure via milk.
aimsTo investigate the transfer of rac-tramadol and its rac-O-desmethyl metabolite into transitional milk, and assess unwanted effects in the breastfed infant.
methodsTramadol HCl (100 mg six hourly) was administered to 75 breastfeeding mothers for postoperative analgesia on days 2-4 after Caesarian section. Milk and plasma samples were collected after administration of four or more doses. Rac-tramadol and rac-O-desmethyltramadol were measured by high performance liquid chromatography. Milk : plasma ratio (M : P) and infant doses were calculated by standard methods. The behavioural characteristics of the exposed breastfed infants and a matched control group of infants not exposed to tramadol were also studied. RESULTS At steady-state, mean (95% CI) M : P was 2.2 (2.0, 2.4) for rac-tramadol and 2.8 (2.5, 3.1) for rac-O-desmethyltramadol. The estimated absolute and relative infant doses were 112 (102, 122) microg kg(-1) day(-1) and 30 (28, 32) microg kg(-1) day(-1), and 2.24% (2.04, 2.44)% and 0.64% (0.59, 0.69)% for rac-tramadol and rac-O-desmethyltramadol, respectively. The exposed infants and control breastfed infants had similar characteristics, including Apgar scores at birth and Neurologic and Adaptive Capacity Scores.
conclusionsThe combined relative infant dose of 2.88% at steady-state was low. The similarity of NACS in exposed infants and controls suggests that there were no significant behavioural adverse effects. We conclude that short-term maternal use of tramadol during establishment of lactation is compatible with breastfeeding.
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