Intravensko lajšanje porodnih bolecin z remifentanilom, ki si ga uravnava porodnica sama – vpliv hitrosti dovajanja posameznih odmerkov na kvaliteto lajšanja porodnih bolecin in varnost uporabe Intravenous patient controlled pain relief during labour with remifentanil - impact of bolus application speed on the quality of pain relief and the safety of remifentanil use - Remi - PCA - hitrosti

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017659-83-SI

Enrollment

Registered

2009-12-11

Start date

2010-04-08

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

labour pain MedDRA version: 12.1 Level: LLT Classification code 10059204 Term: Labour pain

Interventions

Trade Name: Ultiva Product Name: Ultiva Pharmaceutical Form: Powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 , ...)

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective of the trial is to find optimal speed of remifentanil bolus infusion that mother launch itself for labour pain relief in patient controlled infusion mode in terms of pain reduction, satisfaction with the method and frequency of side effects - safety for the newborn and mother.;Secondary Objective: Secondary endpoints are to describe the frequency of accompanying phenomena, remifentanil impact on the duration of the first birth period, impact on the way of deliveryand the need for more intensive measures with the newborn immediately at birth and in the immediate postpartum period;Primary end point(s): -Is there a difference in the quality of pain relief during labor between groups? (N-VAS-pain, VAS-satisfaction) - What is the probability of developing neonatal respiratory brakes? (occurrence early apnoic attackes, beginig of breastfeeding, impaired sucking, early neurological status at birth and measures at newborn necessary at the birth) - Is the use of birth safe? (maternal: sedation, saturation, respiratory rate, heart rate, blood pressure; baby: CTG, Apgar 1st and 5 and 10 minutes	—

Measure

Time frame

Main Objective: Main objective of the trial is to find optimal speed of remifentanil bolus infusion that mother launch itself for labour pain relief in patient controlled infusion mode in terms of pain reduction, satisfaction with the method and frequency of side effects - safety for the newborn and mother.;Secondary Objective: Secondary endpoints are to describe the frequency of accompanying phenomena, remifentanil impact on the duration of the first birth period, impact on the way of deliveryand the need for more intensive measures with the newborn immediately at birth and in the immediate postpartum period;Primary end point(s): -Is there a difference in the quality of pain relief during labor between groups? (N-VAS-pain, VAS-satisfaction) - What is the probability of developing neonatal respiratory brakes? (occurrence early apnoic attackes, beginig of breastfeeding, impaired sucking, early neurological status at birth and measures at newborn necessary at the birth) - Is the use of birth safe? (maternal: sedation, saturation, respiratory rate, heart rate, blood pressure; baby: CTG, Apgar 1st and 5 and 10 minutes

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Countries

Slovenia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026