Intranasal Fentanyl in Treatment of Labour Pain (fentaobs)

Kuopio University Hospital

Status and phase: Completed; Phase 4

Conditions: Labor Pain

Treatments: Drug: intranasal fentanyl 50 microg dose up to 250 microg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02571179

KUH12_04_2010

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intranasal fentanyl 50 microg/dose

Experimental group

Description:

patient was given intranasal fentanyl 50 microg/dose up to 250 microg

Treatment:

Drug: intranasal fentanyl 50 microg dose up to 250 microg