fentaobs: Intranasal Fentanyl in Treatment of Labour Pain
Sponsor
Kuopio University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02571179
Collaborator
Admescope Ltd (Industry)
20
1
1
83
0.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Intranasal fentanylIntranasal fentanyl
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety
Study Start Date
:
Jan 1, 2011
Anticipated Primary Completion Date
:
Dec 1, 2017
Anticipated Study Completion Date
:
Dec 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intranasal fentanyl 50 microg/dose patient was given intranasal fentanyl 50 microg/dose up to 250 microg |
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.
|
Outcome Measures
Primary Outcome Measures
- Fentanyl maximum concentration [From the first intranasal fentanyl dose to birth of the newborn up to 48 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kuopio University Hospital | Kuopio | Northern savo | Finland | 70029 |
Sponsors and Collaborators
- Kuopio University Hospital
- Admescope Ltd
Investigators
- Principal Investigator: Merja Kokki, PhD, Kuopio University Hospital, Kuopio, Finland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merja Kokki,
MD, PhD,
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT02571179
Other Study ID Numbers:
- KUH12_04_2010
First Posted:
Oct 8, 2015
Last Update Posted:
Apr 12, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Merja Kokki,
MD, PhD,
Kuopio University Hospital
Additional relevant MeSH terms: