Labor pain at the onset of labor in previously healthy women with normal pregnancy MedDRA version: 17.1 Level: LLT Classification code 10059210 Term: Labor pain System Organ Class: 100000004868
Conditions
Interventions
Trade Name: Oxanest
Product Name: Oxanest
Pharmaceutical Form: Injection
INN or Proposed INN: Oxycodone
CAS Number: 124-90-3
Other descriptive name: OXYCODONE HYDROCHLORIDE
Concentration unit: mg/ml m
Sponsors
Merja Kokki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Oxycodone intended to use for labor pain treatment Age = 18 years Written informed consent Full term pregnancy (minimum gestational weeks 37) Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: No oxycodone planned to be used Age less than 18 years No informed consent Not full term pregnancy (less than gestational weeks 37) Allergy to study medicine or the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of oxycodone on placental and fetal circulation;Secondary Objective: The efficacy of oxycodone, concentrations of oxycodone during the study and at birth, the safety of oxycodone to the mother and newborn;Primary end point(s): Placental and fetal circulation during oxycodone administration. ;Timepoint(s) of evaluation of this end point: Before study drug administration, 30, 60, 120 minutes after study drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The status orf neonate is assessed using Apgar, NACS (Neurologic and Adaptive Capacity Score) and amplitude integrated EEG (aEEG), 24- channel EEG maternal and neonatal concentrations of oxycodone and its metabolites, the efficacy of oxycodone.;Timepoint(s) of evaluation of this end point: The newborn is assessed with Apgar, NACS, aEEG during the first 3 hours after birth. Materal oxycodone concentrations are measured during two hours of Doppler ultrasound assessment, and right after birth. The newborn oxycodone and its metabolite concentrations are measured from umbilical artery and vein after birth when umbilical cord is clamped and cut. The efficacy of oxycodone is assessed during the two hour Doppler ultrasound assessment period. 24-channel EEG is registered during the following day of the birth | — |
Countries
Finland
Contacts
Public ContactMerja Kokki
Kuopio University Hospital
Outcome results
None listed