Pain Clinical Trial
Official title:
Disposition of Intravenous Paracetamol in Young Women, Including During Pregnancy, in Postpartum or When on Oral Contraceptives
Compared to early postpartum (10-15 weeks) observations, paracetamol clearance was
significantly higher (21.1 vs 11.7 l.h-1, + 80 %) at delivery. This higher clearance was due
to a disproportional increase in glucuronidation (11.6 vs 4.76 l.h-1, + 144 %), a
proportional increase in oxidation clearance (4.95 vs 2.77 l.h-1, 78 %) and primary renal
clearance (1.15 vs 0.75 l.h-1, 53 %) [KUlo et al, Int J Obstet Anesth]. This increase in
glucuronidation clearance may in part be driven by oestradiol, and may explain within and
between individual differences in paracetamol metabolism (e.g. oral contraceptives,
follicular vs luteal phase, postpartum, pregnancy, or duration of pregnancy) in young women.
Based on a pooled analysis, investigators aimed to further explore the impact of these
covariates on paracetamol metabolism based on plasma and urine collections in women at
delivery, in postpartum (early, or late) and healthy volunteers, either or not on oral
contraceptives (OC) following intravenous (iv) paracetamol administration.
This study aims to perform a pooled analysis of:
1. Paracetamol PK data recently published in 47 pregnant women. In these cases, iv
paracetamol was administered q6h after delivery (caesarean) for 24 h. 8 were recruited
a second time for an additional single dose pK study in postpartum (Kulo et al, Br J
Clin Pharmacol 2013).
2. The PK data as initially published by Gregoire et al, but limited to female volunteers,
all on oral contraceptives (n=14) (Gregoire et al, Clin Pharm Ther 2007)
3. A dataset in 8 young women not on oral contraceptives, iv paracetamol, single dose.
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