ebulised fentanyl for labour pain in low risk patients– a pharmacokinetic and feasibility study

Phase 4

• Conditions: Pain during labour; Reproductive Health and Childbirth - Childbirth and postnatal care; Anaesthesiology - Pain management

• Registration Number: ACTRN12622001483741
• Lead Sponsor: The Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-28
• Last Update Posted: 12 December 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified