Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
oksisynnytys
1 other identifier
observational
90
1 country
1
Brief Summary
Oxycodone is used to treat early labour pain instead of meperidine. However, the efficacy and effects of oxycodone to the newborn has not been studied. In the present study, patient who has received oxycodone is asked about pain relief and after labour single venous blood sample from the parturient and umbilical cord are taken for the analysis of oxycodone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
Longer than P75 for all trials
1 active site
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
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 16, 2023
March 1, 2023
11.2 years
October 8, 2015
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain measured with numerical rating scale
Pain measured with numerical rating scale 0-10 (0=no pain, 10 = worst pain)
from the time of oxycodone administration up to the birth of newborn, maximum of 48 hours
Study Arms (1)
Parturients with oxycodone
Parturients who were given oxycodone
Interventions
oxycodone 0,1/kg up to 10 mg sc.
Eligibility Criteria
Parturients who are in early labor and need some pain medication.
You may qualify if:
- Oxycodone for pain relief
- age 18 years or more
- given informed consent
You may not qualify if:
- no oxycodone
- age less than 18 years
- no informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- Admescope Ltdcollaborator
Study Sites (1)
Kuopio University Hospital
Kuopio, Northern Savonia, 70029, Finland
Biospecimen
venous blood for the analysis of oxycodone
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merja Kokki, MD, PhD
Kuopio University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 8, 2015
First Posted
October 15, 2015
Study Start
October 1, 2012
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
March 16, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share