NCT02571179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

10.2 years

First QC Date

October 5, 2015

Last Update Submit

March 14, 2023

Conditions

Labor Pain

Keywords

Labor painFentanylTransmucosal

Outcome Measures

Primary Outcomes (1)

  • Fentanyl maximum concentration

    From the first intranasal fentanyl dose to birth of the newborn up to 48 hours

Study Arms (1)

Intranasal fentanyl 50 microg/dose

EXPERIMENTAL

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

Drug: intranasal fentanyl 50 microg dose up to 250 microg

Interventions

intranasal fentanyl 50 microg dose up to 250 microgDRUG

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healthy parturients with uncomplicated, single gestation pregnancies, full term (38-42 weeks of gestation) pregnancy, agreed to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Merja Kokki, PhD

    Kuopio University Hospital, Kuopio, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intranasal fentanyl
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 8, 2015

Study Start

January 1, 2011

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations

FI(1)