None listed
Conditions
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.
Interventions
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 de
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.
Sponsors
Western 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 No maximum
Healthy volunteers
Yes
Inclusion criteria
18 years old and over; Singleton pregnancy; Term – at least 37 weeks; Prima Gravida.
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).
Outcome results
None listed