laborpain MedDRA version: 9.1 Level: LLT Classification code 10052803 Term: Analgesic effect
Conditions
Interventions
Trade Name: Ultiva
Product Name: remifentanil
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: • Age = 18 years • Between 37 and 42 weeks of gestation • Singleton pregnancy • ASA physical status I or II Are the trial subjects under 18? no 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: • ASA physical status = III • Morbid obesity (BMI = 40 kg/m2) • Substance abuse history • High risk patients: including pre-eclampsia (diastolic pressure = 100 mmHg, proteinuria), severe asthma (daily use of medication), insulin dependent diabetes mellitus, hepatic insufficiency or renal failure • Premature labor • Drug allergy; history of hypersensitivity to opioid or local anesthetic substances • Cervical dilation > 5cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the analgesic efficacy and safety of remifentanil, administered as patient-controlled analgesia (PCA), with epidural analgesia. The evaluation will be based upon the following outcome parameters: A. Quality of pain relief as determined by Visual Analogue Scale scores B. Patient satisfaction C. Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone ;Secondary Objective: ;Primary end point(s): A. Quality of pain relief as determined by Visual Analogue Scale scores B. Patient satisfaction C. Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone | — |
Countries
Netherlands
Outcome results
None listed