Intranasal Fentanyl in Treatment of Labour Pain

Labor Pain Clinical Trial

— fentaobs  

Official title:

Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571179
• Other study ID #: KUH12_04_2010
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: March 2021

Study information

• Verified date: March 2023
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• intranasal 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.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	Admescope Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fentanyl maximum concentration		From the first intranasal fentanyl dose to birth of the newborn up to 48 hours