Skip to main content
Clinical Trials/ACTRN12622001483741
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.

Registry
who.int
Start Date
November 28, 2022
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
The Royal Brisbane and Women's Hospital

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