CompletedPhase 4ACTRN12609000006246

Self-administered fentanyl for birthing women.

An evaluation of the safety and effectiveness of patient-controlled intranasal fentanyl for relieving pain in birthing women.


Sponsor

Western Health

Enrollment

50 participants

Start Date

Sep 30, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for women aged 18 and older who are pregnant with a single baby at full term (at least 37 weeks) and expecting their first child. It tests whether self-administered fentanyl nasal spray is effective for pain relief during labor. Participants use the spray as needed during labor and rate their pain levels.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 fen

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.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12609000006246


Related Trials