Intranasal Fentanyl in Treatment of Labour Pain
Phase 4
Completed
- Conditions
- Labor Pain
- Interventions
- Drug: intranasal fentanyl 50 microg dose up to 250 microg
- Registration Number
- NCT02571179
- Lead Sponsor
- Kuopio University Hospital
- Brief Summary
Physiological changes during pregnancy are known to affect the pharmacokinetics of many drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in pregnant patients has not been established. The investigators studied pharmacokinetics of intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal safety after administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
- healthy parturients with uncomplicated, single gestation pregnancies, full term (38-42 weeks of gestation) pregnancy, agreed to participate
Exclusion Criteria
- a disease that might affect hepatic or renal function, contraindications to opioid analgesics, fetal growth retardation, signs of fetal asphyxia by cardiotocography, meconium stained amniotic fluid or placental insufficiency. The subjects should not have received fentanyl during the previous 14 days.
Not agreed to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intranasal fentanyl 50 microg/dose intranasal fentanyl 50 microg dose up to 250 microg patient was given intranasal fentanyl 50 microg/dose up to 250 microg
- Primary Outcome Measures
Name Time Method Fentanyl maximum concentration From the first intranasal fentanyl dose to birth of the newborn up to 48 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Northern Savo, Finland