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Research on the Safety of Articaine in Breastfeeding

Research on the Safety of Articaine in Breastfeeding

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082053
Enrollment
Unknown
Registered
2024-03-19
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

None

Interventions

A:Collect 3mL blood sample at 0.25 h (±5min) and 3mL milk samples at 0.25 h (± 5 min), 0.5 h (± 5 min), 1 h (±10min), 1.5 h (± 10 min), 2h (±10min) and 3h (±10min)from volunteers after articaine bucca
B:Milk was emptied before administration and at 3h after administration, and collect blood samples at 0.25 h after administration and accumulated milk between 0 and 3h after buccal mucosal infiltratio

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All of the following criteria must be met: Fully informed and voluntarily sign an informed consent form before any specific research procedures are carried out; Lactating women without systemic disease, weight =40kg, age =18 years

Exclusion criteria

Exclusion criteria: If any of the following criteria are met, you cannot be enrolled in this study: (1) Smoking and drinking; (2) Contraindications to local anesthetics and their associated vasoconstrictors: including known or suspected allergic reactions to amide local anesthetics or sulfites; (3) History of cardiovascular disease, including unstable angina, arrhythmia, or treated or untreated hypertension, systolic blood pressure greater than 140 mm or diastolic blood pressure greater than 90 mm Hg; (4) Severe or currently symptomatic bronchial asthma;(5) soft tissue infection around any injection site; (6) Recent use of the following drugs: nonselective beta blockers, monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazines, butylphenols, vasopressors, and ergot alkaloids. (7) Other factors, including but not limited to other medical history (e.g., history of mental disorders), vital signs, abnormalities, etc., that may affect the study results and interfere with their participation in the entire study, according to the investigator's judgment.

Design outcomes

Primary

MeasureTime frame
Milk Drug Concentration;

Secondary

MeasureTime frame
Plasma Concentration;

Countries

China

Contacts

Public ContactQuan Jing

Peking Union Medical College Hospital

pumchjq@aliyun.com+86 139 1117 6486

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026