A comparison of fentanyl with pethidine for pain relief during childbirth.

Obstetric analgesia: A comparison of intranasal or subcutaneously administered fentanyl with intramuscular administered pethidine in labour and its effects on mother and baby.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001027202

Enrollment

150

Registered

2009-11-27

Start date

2010-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

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.

Outcome results