Oxycodone in Treatment of Early Labour Pain Efficacy and Safety (oksisynnytys)

March 14, 2023 updated by: Merja Kokki, Kuopio University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Northern Savo
      • Kuopio, Northern Savo, Finland, 70029
        • Recruiting
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Parturients who are in early labor and need some pain medication.

Description

Inclusion Criteria:

  • Oxycodone for pain relief
  • age 18 years or more
  • given informed consent

Exclusion Criteria:

  • no oxycodone
  • age less than 18 years
  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parturients with oxycodone
Parturients who were given oxycodone
Other: oxycodone
oxycodone 0,1/kg up to 10 mg sc.
Other Names:
  • Ocycodone administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measured with numerical rating scale
Time Frame: from the time of oxycodone administration up to the birth of newborn, maximum of 48 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Admescope Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 12, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH26062012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor Pain

Clinical Trials on oxycodone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe