Study of Analgesics Drug and Human Milk Transfer in Mature Milk, to Avoid Breastfeeding Cessation Without Scientific Probes

Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01854411

Acronym

ANTALAIT

Enrollment

Registered

2013-05-15

Start date

2011-09-01

Completion date

2014-11-01

Last updated

2026-03-04

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

Conditions

Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk

Keywords

Analgesics, Ibuprofene, Ketoprofene, Breastmilk, Relative Infant Dose, Theoric Infant Dose

Brief summary

The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into mature breastmilk that could allowed breastfeeding during a long time

Detailed description

Analgesics are frequently used to prevent and treat pain and inflammatory disease. Due to a lack of information on drug's human milk transfer, breastfeeding is sometimes contraindicated. Mothers are advised to either stop breastfeeding or if they don't, not to treat themselves. Since the fatal neonatal case with codeine during breastfeeding, analgesics are being reviewed. Ibuprofen seems to have the best benefit-risk ratio during the post-partum period. However there are no pharmacologic data about the use of ibuprofen during breastfeeding, after the colostrum phase. This study aims to determine the relative infant dose (RID) of ibuprofen in human mature milk. Considering the increased interest in NSAIDs in light of the codeine case, this is an important information. It will help health practitioners when advising and treating breastfeeding women.

Interventions

OTHERanalgesic measure

ibuprofen and ketoprofen measured into breast milk

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

Inclusion criteria

* breastfeeding women after the first week of delivery * breastfeeding women treated by ketoprofen or ibuprofen per os more than 24 hours * Written Informed Consent

Exclusion criteria

* breastfeeding women treated by naproxene * Curator or justice decision's

Design outcomes

Primary

Measure	Time frame
concentration of ibuprofene in human mature milk.	6 months
concentration of ketoprofene in human mature milk	6 months

Secondary

Measure	Time frame	Description
comparison between ibuprofene and ketoprofene concentrations in the human breastmilk	6 months	To compare the concentrations of ibuprofene and ketoprofene in the human breastmilk in correlation with the maturity

Countries

France

Contacts

STUDY_CHAIRvirginie rigourd, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026