Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001483741
Ethics application status
Approved
Date submitted
15/11/2022
Date registered
28/11/2022
Date last updated
28/11/2022
Date data sharing statement initially provided
28/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Nebulised fentanyl for labour pain in low risk patients– a pharmacokinetic and feasibility study
Scientific title
Nebulised fentanyl for labour pain – a pharmacokinetic and feasibility study in low risk pregnant patients
Secondary ID [1] 308417 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The FUN Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain during labour 328220 0
Condition category
Condition code
Reproductive Health and Childbirth 325268 325268 0 0
Childbirth and postnatal care
Anaesthesiology 325304 325304 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324870 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333122 0
Number of women consenting to participate divided by the number of women eligible to participate. Assessed by auditing the study recruitment log.
Timepoint [1] 333122 0
Upon completion of recruitment.
Primary outcome [2] 333123 0
Describe the plasma pharmacokinetics of a single dose of nebulised fentanyl in 15 labouring pregnant patients.
Concentration of fentanyl
half life
elimination half life
clearance
volume of distribution
Timepoint [2] 333123 0
Samples collected at 5, 10, 15, 30, 60, 120 and if possible, 180, 240 minutes after the dose
Secondary outcome [1] 415882 0
Maternal pain score assessed on a visual analogue scale, 100mm, horizontal
Timepoint [1] 415882 0
Immediately prior to the intervention, immediately after the intervention, then at dose plus 5 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes. Then 15 minutely at 75 minutes, 90 minutes, 105 minutes, 120 minutes.
Secondary outcome [2] 415883 0
Maternal sedation score, measured using the Ramsay sedation score
Timepoint [2] 415883 0
At dose plus 5 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes. Then 15 minutely at 75 minutes, 90 minutes, 105 minutes, 120 minutes.
Secondary outcome [3] 415884 0
Maternal respiratory rate calculated by the number of breaths per minute by clinical observation
Timepoint [3] 415884 0
At dose plus 5 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes. Then 15 minutely at 75 minutes, 90 minutes, 105 minutes, 120 minutes.
Secondary outcome [4] 415885 0
Maternal nausea self-reported as present/absent
Timepoint [4] 415885 0
At dose plus 5 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes. Then 15 minutely at 75 minutes, 90 minutes, 105 minutes, 120 minutes.
Secondary outcome [5] 415886 0
Maternal vomiting documented as present or absent by clinical observation of vomiting
Timepoint [5] 415886 0
At dose plus 5 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes. Then 15 minutely at 75 minutes, 90 minutes, 105 minutes, 120 minutes.
Secondary outcome [6] 415887 0
Fetal heart rate abnormalities detected either by:

if CTG used, according to the Intrapartum Fetal Surveillance (IFS) Queensland Clinical Guideline, classified in “normal” (low probability of fetal compromise), “abnormal - fetal compromise unlikely”, “abnormal - fetal compromise may be” and “abnormal - fetal compromise likely. CTG trace will be observed live.

or

If CTG is not used, the detection of fetal bradycardia in the 2 hours following administration will be measured by hand-held doppler, documented as present or absent.
Timepoint [6] 415887 0
Within 2 hours post dose
Secondary outcome [7] 415888 0
Umbilical cord blood level of fentanyl
Timepoint [7] 415888 0
Within 15 minutes of birth
Secondary outcome [8] 415889 0
Maternal satisfaction with nebulised fentanyl, meausured on 5-point Likert scales
Timepoint [8] 415889 0
Day 1 post-delivery
Secondary outcome [9] 415890 0
Maternal experience of nebulised fentanyl assessed by qualitative analysis of free text comments
Timepoint [9] 415890 0
Day 1 post-delivery
Secondary outcome [10] 415894 0
Breastfeeding initiation - 4 questions (yes/no) and 5 options to choose from regarding problems encountered. Unvalidated questionnaire designed by experts for this study.
Timepoint [10] 415894 0
Day 1 following delivery
Secondary outcome [11] 415895 0
Midwife satisfaction with nebulised analgesia, measured on 5 point Likert scale
Timepoint [11] 415895 0
Day 1 following delivery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Participant characteristics will be summarised using descriptive statistics. Likert scale responses will be presented as number (%) and presented as frequency histograms. Free-text comments will be transcribed verbatim. Two authors will code the comments then independently apply conventional content analysis to interpret the data. The themes and concepts will be identified and illustrative quotes presented.
The proposed sample size is in line with previous similar studies and we anticipate it will describe the plasma population pharmacokinetics with an acceptable level of bias and precision. Pharmacokinetic modelling will be performed using Pmetrics 1.5.0 with RStudio 0.99.902 and digital compiler Gfortran 5.2 (The Fortran Company, Chandler, AZ).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
1/02/2024
Actual
Date of last data collection
Anticipated
2/02/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23571 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 38993 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 312668 0
Charities/Societies/Foundations
Name [1] 312668 0
The Australian and New Zealand College of Anaesthetists
Country [1] 312668 0
Australia
Primary sponsor type
Hospital
Name
The Royal Brisbane and Women's Hospital
Address
Butterfield St
Herston 4029
Brisbane
Queensland
Country
Australia
Secondary sponsor category [1] 314282 0
None
Name [1] 314282 0
Address [1] 314282 0
Country [1] 314282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311971 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 311971 0
Human Research Ethics Office Level 7, Block 7
Royal Brisbane and Women’s Hospital
Butterfield Street, Herston, Qld 4029
Ethics committee country [1] 311971 0
Australia
Date submitted for ethics approval [1] 311971 0
22/03/2022
Approval date [1] 311971 0
13/04/2022
Ethics approval number [1] 311971 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123014 0
A/Prof Victoria Eley
Address 123014 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston QLD 4029
Country 123014 0
Australia
Phone 123014 0
+61 7 36467154
Fax 123014 0
Email 123014 0
v.eley@uq.edu.au
Contact person for public queries
Name 123015 0
A/Prof Victoria Eley
Address 123015 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston QLD 4029
Country 123015 0
Australia
Phone 123015 0
+61 7 36467154
Fax 123015 0
Email 123015 0
v.eley@uq.edu.au
Contact person for scientific queries
Name 123016 0
A/Prof Victoria Eley
Address 123016 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston QLD 4029
Country 123016 0
Australia
Phone 123016 0
+61 7 36467154
Fax 123016 0
Email 123016 0
v.eley@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.