NCT02571179

Intranasal Fentanyl in Treatment of Labour Pain

Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labor Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2015-10-08
• Last updated: 2023-03-16

Locations

1 site across 1 country: Finland