Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety

Kuopio University Hospital1 site in 1 country20 target enrollmentJanuary 2011

ConditionsLabor Pain

Interventionsintranasal fentanyl 50 microg dose up to 250 microg

Drugsintranasal fentanyl 50 microg dose up to 250 microg

Overview

Phase: Phase 4
Intervention: intranasal fentanyl 50 microg dose up to 250 microg
Conditions: Labor Pain
Sponsor: Kuopio University Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: Fentanyl maximum concentration
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

March 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Kuopio University Hospital

Responsible Party

Principal Investigator

Merja Kokki

MD, PhD

Kuopio University Hospital

Eligibility Criteria

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