Self-administered fentanyl for birthing women.

Phase 4

Completed

• Conditions: Childbirth; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12609000006246
• Lead Sponsor: Western Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Requirement for additional analgesia[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 Measures

Name	Time	Method
Pain score.[Pain score will be measured during childbirth at 30 minute intervals by the midwife caring for the patient on a data form.]