Labor Pain
Conditions
Keywords
Labor pain, Fentanyl, Transmucosal
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.
Interventions
DRUGintranasal fentanyl 50 microg dose up to 250 microg
When contraction pain was ≥ 5/10 (numerical rating scale 0= no pain, 10= worst pain), the parturient was given a intranasal fentanyl 50 µg dose. After 15 minutes, if contraction pain was still ≥ 5/10, a second 50 µg intranasal dose was administered. Fentanyl was administered every 15 minute until contraction pain decreased to less than 5/10 or until the maximum fentanyl dose of 250 µg was administered.
Sponsors
Admescope Ltd
Kuopio University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intranasal fentanyl
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fentanyl maximum concentration | From the first intranasal fentanyl dose to birth of the newborn up to 48 hours |
Countries
Finland
Outcome results
None listed