ACTRN12622001483741
Not yet recruiting
Phase 4
ebulised fentanyl for labour pain – a pharmacokinetic and feasibility study in low risk pregnant patients
The Royal Brisbane and Women's Hospital0 sites15 target enrollmentNovember 28, 2022
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Royal Brisbane and Women's Hospital
- Enrollment
- 15
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age greater than or equal to 18 years and less than or equal to 50 years, gestation greater than or equal to 37 weeks, early pregnancy body mass index greater than or equal to 16 and less than or equal to 40 kg/m2, planning a vaginal delivery or a vaginal birth after caesarean section, able to understand information and consent form in English and provide informed consent.
- •Midwives who are providing clinical care for participants will be offered the opportunity to voluntarily and in a de\-identified fashion to provide feedback on the use of nebulised fentanyl.
Exclusion Criteria
- •Multiple pregnancy, fetus with congenital anomaly, pre\-eclampsia, cardiovascular or respiratory disease with New York Heart Association (NYHA) score \>2, epilepsy on medication, diabetes on medication, elevated serum creatinine (\>70 µmol/L), known opioid misuse, allergy to fentanyl, fentanyl administered by any route in the 24 hours prior to active labour.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
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