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Trial registered on ANZCTR


Registration number
ACTRN12609000006246
Ethics application status
Approved
Date submitted
19/11/2008
Date registered
6/01/2009
Date last updated
10/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-administered fentanyl for birthing women.
Scientific title
An evaluation of the safety and effectiveness of patient-controlled intranasal fentanyl for relieving pain in birthing women.
Secondary ID [1] 287744 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PCIF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childbirth 3987 0
Condition category
Condition code
Reproductive Health and Childbirth 4186 4186 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-comparative study.
Participants will self-administer intranasal fentanyl during childbirth as a form of analgesia.
Non-comparative study.
It is expected that the use of intranasal fentanyl during childbrth will enhance the birthing experience, evidenced by 1) reduiction in pain score during childbirth, and 2) patient satisfaction.
Mode of administration: Self-administered intranasal administration using a Go-Medical intranasal device.
Dose: 54mcg per intranasal spray. Go-medical device will have a 3-minute lock-out.
Duration: Administration during childbirth only.
Follow-up: Participants will be interviewed within 24-48 hours of birth for information regarding satisfaction with intervention.
Intervention code [1] 3708 0
Treatment: Drugs
Comparator / control treatment
No Comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5075 0
Requirement for additional analgesia
Timepoint [1] 5075 0
Assessment of requirement for additional analgesia will be assessed during childbirth at 30-minute intervals. Additional analgesia required by the participant throughout childbirth will be recorded by midwives on a data form.
Secondary outcome [1] 8527 0
Pain score.
Timepoint [1] 8527 0
Pain score will be measured during childbirth at 30 minute intervals by the midwife caring for the patient on a data form.

Eligibility
Key inclusion criteria
18 years old and over;
Singleton pregnancy;
Term – at least 37 weeks;
Prima Gravida.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Failure to provide consent;
Complicated pregnancy – i.e. – no pregnancy induced hypertension, pre-eclampsia, gestational diabetes mellitus;
Abnormal foetal positioning i.e. breech;
Placental abnormalities;
Non-singleton pregnancy;
Allergy to opioid analgesia;
Bronchial asthma
Myasthenia gravis;
Opioid Tolerance including regular use of methadone, buprenorphine, heroin, morphine, oxycodone;
Chronic nasal problems i.e. hay-fever, sinusitis, common cold;
Inability to self administer Patient-Controlled Intranasal Fentanyl (PCIF).

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)
The Caseload Midwife will identify potential participants. Participants will be asked about eligibility criteria, in particular presence of exclusive medical conditions (no pregnancy induced hypertension, pre-eclampsia, gestational diabetes mellitus; abnormal foetal positioning i.e. breech; placental abnormalities; non-singleton pregnancy; allergy to opioid analgesia; bronchial asthma myasthenia gravis; opioid tolerance; chronic nasal problems i.e. hay-fever, sinusitis, common cold).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4187 0
Self funded/Unfunded
Name [1] 4187 0
Address [1] 4187 0
Country [1] 4187 0
Primary sponsor type
Hospital
Name
Western Health
Address
Sunshine Hospital, 176 Furlong Rd, St Albans, VIC 3021
Country
Australia
Secondary sponsor category [1] 3761 0
None
Name [1] 3761 0
Address [1] 3761 0
Country [1] 3761 0
Other collaborator category [1] 484 0
University
Name [1] 484 0
Victoria University
Address [1] 484 0
School of Nursing and Midwifery, McKechnie St, St Albans, VIC 3021
Country [1] 484 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6241 0
Melbourne Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 6241 0
Ethics committee country [1] 6241 0
Australia
Date submitted for ethics approval [1] 6241 0
28/11/2008
Approval date [1] 6241 0
04/06/2009
Ethics approval number [1] 6241 0
2008.229

Summary
Brief summary
The pain of birthing may be the most severe type of pain a woman will experience in her lifetime. Analgesia in childbirth remains controversial and includes the use of non-pharmacological and pharmacological measures including parenteral (intravenous, intramuscular) opioids (pethidine) and epidural analgesic agents (fentanyl).
Intranasal fentanyl is an alternative, non-invasive route of opioid administration and has been shown to be effective in relieving both acute & chronic pain.
Patient controlled analgesia has also been shown to effective and safe for women in labour and for post-operative analgesia administration.
The primary aim of this study is to assess the safety and efficacy of patient-controlled intranasal fentanyl (PCIF) for analgesia in birthing women. Our secondary objective is to examine patient satisfaction of PCIF within 48 hours of birth.
This will be an uncontrolled non-comparative clinical trial. Participants will self-administer intranasal fentanyl for pain during childbirth.
Participants will include 50 consenting adult women who present to Sunshine Hospital for childbirth and are being managed within the Caseload Model of Care.
Data will be analysed used descriptive statistics.
Trial website
Trial related presentations / publications
Kerr D, Taylor D, Evans B. Patient-controlled intranasal fentanyl analgesia: a pilot study to assess practicality and tolerability during childbirth. Int J Obstet Anesth. http://dx.doi.org/10.1016/j.ijoa.2014.11.006. 2015. 24, 117-123.
Public notes

Contacts
Principal investigator
Name 29136 0
A/Prof Debra Kerr
Address 29136 0
Victoria University
McKechnie St, St Albans
Melbourne, Victoria
deb.kerr@vu.edu.au
Country 29136 0
Australia
Phone 29136 0
61 3 99192053
Fax 29136 0
Email 29136 0
deb.kerr@vu.edu.au
Contact person for public queries
Name 12293 0
A/Prof Debra Kerr
Address 12293 0
Victoria University, School of Nursing and Midwifery, McKechnie St, St Albans, VIC 3021
Country 12293 0
Australia
Phone 12293 0
+61 3 99192053
Fax 12293 0
Email 12293 0
deb.kerr@vu.edu.au
Contact person for scientific queries
Name 3221 0
A/Prof Debra Kerr
Address 3221 0
Victoria University, School of Nursing and Midwifery, McKechnie St, St Albans, VIC 3021
Country 3221 0
Australia
Phone 3221 0
+61 3 99192053
Fax 3221 0
Email 3221 0
deb.kerr@vu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary