None listed
Conditions
Brief summary
Gabapentin and pregabalin are anticonvulsants used in the management of both acute and chronic pain. They offer a potentially useful analgesic adjunct to women in the post-partum period. However, there is limited information about the transfer of these drugs in to breast milk which has lead to safety concerns over their use in breastfeeding mothers. By assigning post-partum mothers not intending to breastfeed to receive a dose of either gabapentin or pregabalin, measurements of plasma and breast milk concentrations can be made without risk of drug transfer to the newborn. This data will then be used to create pharmacokinetic models to estimate absolute and relative infant doses if used in breastfeeding mothers.
Interventions
The study will look at the transfer of gabapentin and pregabalin in to the breast milk of women who will not be breastfeeding in the immediate post-partum period (days 1-4 following childbirth).
Arm 1: participants assigned to receive an oral dose of gabapentin 300mg will have drug levels measured from one venous blood sample and four breast milk samples over the subsequent 24 hours.
Arm 2: participants assigned to receive an oral dose of pregabalin 150mg will have drug levels measured from o
The study will look at the transfer of gabapentin and pregabalin in to the breast milk of women who will not be breastfeeding in the immediate post-partum period (days 1-4 following childbirth). Arm 1: participants assigned to receive an oral dose of gabapentin 300mg will have drug levels measured from one venous blood sample and four breast milk samples over the subsequent 24 hours. Arm 2: participants assigned to receive an oral dose of pregabalin 150mg will have drug levels measured from one venous blood sample and four breast milk samples over the subsequent 24 hours. The assigned drug will be administered at 07.00am with venous and breast milk samples taken over the subsequent 24 hours. The assigned drug may be administered on any one of the days 1-4 following childbirth).
Sponsors
King Edward Memorial Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ASA 1 or 2 2. Post-partum 3. Not planning to breast feed or unable to breast feed initially (eg unwell neonate)
Exclusion criteria
1. Current use of other neuropathic analgesia or anti-epileptic drugs. 2. Contraindication to either study medication (eg obstructive sleep apnoea) 3. History of epilepsy 4. Severe pre-eclampsia with renal impairment
Outcome results
None listed