Trial | NCT02571179  Report issue

Title

Intranasal Fentanyl in Treatment of Labour Pain
Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fentanyl ...

  • Study Participants

    20
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.
Study Started
Jan 31
2011
Primary Completion
Mar 31
2021
Study Completion
Mar 31
2021
Last Update
Mar 16
2023

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.

Intranasal fentanyl 50 microg/dose Experimental

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

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
No Results Posted