None listed
Conditions
Brief summary
Labour and birth can be painful experiences. In Australia, 53% of labouring women use inhaled nitrous oxide. The widespread use of nitrous oxide is currently being reconsidered due to environmental concerns. Without nitrous oxide, there would not be a widely available self-administered, needle-free method of pharmacological labour analgesia. In this pharmacokinetic study, we will evaluate the use of nebulised fentanyl for labour analgesia, obtaining maternal and cord blood samples to measure concentrations in the mother and baby. This will be used to develop a proposed dosing schedule. We will also evaluate patient and midwife experiences. This preliminary research will lead to dosing recommendations and larger clinical evaluations, aiming to provide an additional needle-free option for labour analgesia across Australia.
Interventions
Fentanyl 2 mcg/mL administered over 3-5 minutes by an Aerogen ultra nebuliser.
Once only administration, in the first stage of labour, when pain relief is requested.
Aerogen uses an electrostatic charge to nebulise, not a carrier gas.
Sponsors
The Royal Brisbane and Women's Hospital
Metro North Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Outcome results
None listed