Transfer of parecoxib into breast milk; a study of post-operative use following caesarean section.

A study of post-operative precoxib following caesarean section to evaluate the transfer of parecoxib into breast milk.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12607000396426

Acronym

TROPIC

Enrollment

Registered

2007-08-02

Start date

2007-08-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine the extent of transfer of parecoxib into human breast milk. It is hoped to demonstate that the infant doses of parecoxib received in breast milk of women in early stage lactation and receiving this drug for pain control are not sufficient to cause concern about adverse effects in the neonate.

Interventions

Single dose of parecoxib 40mg intravenously on day 3 or 4 post caesarean section administered to women receiving a conventional non steroidal anti inflammatory drug for routine post-operative analgesia. Four breast milk (colustrum) samples will be taken over the 24 hours following the dose and a single maternal blood sample approx 6-8 hours post dose (coinciding with one of the breast milk samples).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Women post caesarean section requiring conventional non steroidal inflammatory drugss for analgesia on day 3 or 4 following delivery.

Exclusion criteria

Known hypersensitivity to parecoxib or allergy to sulphonamidesrenal dysfunctionknown past or current peptic ulcer disease or gastro-oesophageal refluxhypertensionNSAID or aspirin induced asthmaischaemic heart disease or cerebrovascular diseasewomen with a preterm infant or an infant requiring care in the neonatal nursery< 18 years of age.

Outcome results