RecruitingPhase 4ACTRN12609001027202

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.

Sponsor

Flinders University

Enrollment

150 participants

Start Date

May 1, 2010

Study Type

Interventional

Conditions

Childbirth

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.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two different pain medicines — fentanyl and pethidine — to see which works better and more safely for pain relief during labour and childbirth. Right now pethidine is the most commonly used drug for labour pain, but it can have side effects for both mum and baby. Fentanyl may have fewer side effects. This trial will look at giving fentanyl through the nose (nasal spray) or under the skin, comparing it to the usual pethidine injection. You may be eligible if: - You are a woman aged 18 or older - You are having a healthy, full-term pregnancy (between 37 and 42 weeks) - You are in active labour with regular contractions and your cervix is at least 3 cm dilated You may NOT be eligible if: - You have a history of substance abuse or opioid dependency - You are having a premature labour (before 37 weeks) - You have bronchial asthma - You are allergic to opioid medicines - You have taken antidepressants (MAOIs, SSRIs, or tricyclics) in the last two weeks Talk to your doctor about whether this trial might be right for you.

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.

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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.

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