Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001027202
Ethics application status
Approved
Date submitted
23/11/2009
Date registered
27/11/2009
Date last updated
22/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of fentanyl with pethidine for pain relief during childbirth.
Scientific title
Obstetric analgesia: A comparison of intranasal or subcutaneously administered fentanyl with intramuscular administered pethidine in labour and its effects on mother and baby.
Secondary ID [1] 1149 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childbirth 252251 0
Condition category
Condition code
Reproductive Health and Childbirth 252439 252439 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised into one of three groups.
Group 1. Self administered intranasal fentanyl, under supervision of a midwife.

Group 2. Fentanyl administered subcutaneously

Group 3. Pethidine administered intramuscularly
Intervention code [1] 241583 0
Treatment: Drugs
Comparator / control treatment
The comparator group will be administered intramuscular (IM) pethidine. Observations will be undertaken as for groups one and two. Results will then be compared to review efficacy and safety.
Control group
Active

Outcomes
Primary outcome [1] 253320 0
To determine whether fentanyl administered subcutaneously (s.c) or intranasal (I/N) during childbirth will be at least as efficacious as the current practice of administering IM pethidine.
Timepoint [1] 253320 0
1. Pain scores will be taken once the woman requests a narcotic. This will be undertaken utilising the Visual analogue Scale (VAS) tool. Scores will be collected immediately before injection or inhalation and 30 minutes post administration between contractions. I
Secondary outcome [1] 262400 0
1. To determine whether fentanyl administered s.c or I/N during childbirth will provide fewer adverse effects than that of IM administered pethidine for mother and neonate.
Timepoint [1] 262400 0
Maternal blood pressure, nausea and sedation levels, will be monitored both before and 30 minutes after drug administration. In addition, neonatal effects including Apgar scores at 1 and 5 minutes, whether narcan has been administered to reverse the effect of the narcotic and the time taken for the baby to establish breathing will be examined.
Secondary outcome [2] 262410 0
2. A questionaire will be utilised to explore whether any of the three treatments have an effect on breastfeeding for women who chose to feed their babies in this manner.
Timepoint [2] 262410 0
Breastfeeding outcomes will be reviewed at discharge from hospital and 6 weeks postpartum.

Eligibility
Key inclusion criteria
Healthy women birthing at term (between 37 to 42 weeks gestation). The woman must be in active labour, having regular contractions and a cervical dilatation of at least 3cm.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women with a substance abuse history (opioid tolerance), premature labour, bronchial asthma, a drug allergy or history of hypersensitivity to opioid substances or women who are taking or have taken Monoamine oxidase inhibitors (MAOI), Selective Serotonin Reuptake Inhibitors (SSRI’s) or tricyclics within the previous fourteen days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will be recruited through the antenatal clinics so that consent can be obtained prior to the commencement of labour. Once in labour and upon requesting to be administered a narcotic for pain relief the woman will be asked to select an envelope from a container that identifies which narcotic and mode of administration will be undertaken.
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244061 0
University
Name [1] 244061 0
Flinders University
Country [1] 244061 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 251407 0
None
Name [1] 251407 0
Address [1] 251407 0
Country [1] 251407 0
Other collaborator category [1] 967 0
Hospital
Name [1] 967 0
Flinders Medical Centre
Address [1] 967 0
Flinders Drive, Bedford Pk,
South Australia, 5042
Country [1] 967 0
Australia
Other collaborator category [2] 260567 0
Hospital
Name [2] 260567 0
Women's & Children's Hospital
Address [2] 260567 0
72 King William Rd Adelaide SA
Country [2] 260567 0
Australia
Other collaborator category [3] 260568 0
Hospital
Name [3] 260568 0
Inner North Country Health Services
Address [3] 260568 0
Hutchinson Rd Gawler East
Country [3] 260568 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258160 0
Southern Adelaide Health Service / Flinders University FLINDERS CLINICAL RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 258160 0
Flinders Medical Centre, Flinders Drive BEDFORD PARK SA 5042
Ethics committee country [1] 258160 0
Australia
Date submitted for ethics approval [1] 258160 0
24/11/2009
Approval date [1] 258160 0
Ethics approval number [1] 258160 0
Ethics committee name [2] 286762 0
WCHN Human Research Ethics Committee
Ethics committee address [2] 286762 0
72 King William Rd Adelaide
Ethics committee country [2] 286762 0
Australia
Date submitted for ethics approval [2] 286762 0
Approval date [2] 286762 0
10/11/2010
Ethics approval number [2] 286762 0
REC2284/9/13

Summary
Brief summary
Pethidine is currently the most widely used narcotic administered systemically for the relief of labour pain, but has been shown to have numerous side effects on both mother and neonate. An alternative narcotic, fentanyl when administered intravenously (IV) has been shown to have fewer side effects and a shorter duration of action than does pethidine.

There is a lack of research relating to the use of fentanyl administered during labour via alternative routes. Alternative routes have the benefit of being less invasive, requires fewer resources and provides more autonomy to the midwife providing care. This has particular benefits for rural and remote birthing communities.

This study will examine the safety and efficacy of fentanyl administered by intranasal (IN) or subcutaneous (s.c) routes for pain relief during childbirth for both mother and neonate. It also will investigate possible maternal and neonatal side effects. Outcomes will be compared with intramuscular (IM) pethidine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30536 0
Address 30536 0
Country 30536 0
Phone 30536 0
Fax 30536 0
Email 30536 0
Contact person for public queries
Name 13783 0
Julie Fleet
Address 13783 0
GPO Box 2100
Adelaide SA 5001
Country 13783 0
Australia
Phone 13783 0
+61 882012071
Fax 13783 0
Email 13783 0
[email protected]
Contact person for scientific queries
Name 4711 0
Julie Fleet
Address 4711 0
GPO Box 2100
Adelaide SA 5001
Country 4711 0
Australia
Phone 4711 0
+61 882012071
Fax 4711 0
Email 4711 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA comparison of fentanyl with pethidine for pain relief during childbirth: A randomised controlled trial.2015https://dx.doi.org/10.1111/1471-0528.13249
N.B. These documents automatically identified may not have been verified by the study sponsor.