Back to resultsIntranasal Fentanyl in Treatment of Labour Pain (fentaobs)
Primary Purpose
Labor Pain
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
intranasal fentanyl 50 microg dose up to 250 microg
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring Labor pain, Fentanyl, Transmucosal
Eligibility 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
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intranasal fentanyl 50 microg/dose
Arm Description
patient was given intranasal fentanyl 50 microg/dose up to 250 microg
Outcomes
Primary Outcome Measures
Fentanyl maximum concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT02571179
First Posted
October 5, 2015
Last Updated
March 14, 2023
Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02571179
Brief Title
Intranasal Fentanyl in Treatment of Labour Pain
Acronym
fentaobs
Official Title
Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Labor pain, Fentanyl, Transmucosal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Intranasal fentanyl
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal fentanyl 50 microg/dose
Arm Type
Experimental
Arm Description
patient was given intranasal fentanyl 50 microg/dose up to 250 microg
Intervention Type
Drug
Intervention Name(s)
intranasal fentanyl 50 microg dose up to 250 microg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fentanyl maximum concentration
Time Frame
From the first intranasal fentanyl dose to birth of the newborn up to 48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merja Kokki, PhD
Organizational Affiliation
Kuopio University Hospital, Kuopio, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Northern Savo
ZIP/Postal Code
70029
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intranasal Fentanyl in Treatment of Labour Pain
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