Intravensko lajšanje porodnih bolecin z remifentanilom, ki si ga uravnava porodnica sama – primerjava protokola brez uporabe bazalne infuzije in protokola z uporabo bazalne infuzije glede kvalitete lajšanja porodnih bolecin in varnosti uporabeIntravenous patient controlled pain relief during labour with remifentanil - a comparison of the protocol without the use of basal infusion and the protocol using a basal infusion on the quality of pain relief and the safety of its use - Remi - PCA - koncentracije

• Conditions: labour pain; MedDRA version: 12.0Level: LLTClassification code 10059204Term: Labour pain

• Registration Number: EUCTR2009-016752-52-SI
• Lead Sponsor: BGP Kranj

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Age over 18 years
- Body weight between 50 and 100 kg
- Spontaneous or induced labour
- Request for the relief of pain birth
- Gestational age of fetus at least 35 weeks
- Cephalic presentation
- CTG normal before the start of pain relief

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Allergy to opioids
- History of illegal drugs use or alcohol dependency
- Age under 18 years
- Diabetes, pregnancy induced arterial hypertension
- Contraindication for use of labour epidural analgesia (bleeding disorders, infection at the injection site, fear of epidural puncture and its consequences, ...)
- Pathological CTG before the start of pain relief / fetal distress from any cause
- Twins, breech presentation
- IUGR with an estimated fetal weight <2500 g
- Congenital / chronic disease in a child found after birth (hereditary diseases, malformations, inherent metabolic disorders , ...)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified