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oksisynnytys: Oxycodone in Treatment of Early Labour Pain Efficacy and Safety

Sponsor
Kuopio University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02575677
Collaborator
Admescope Ltd (Industry)
90
Enrollment
1
Location
62
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: oxycodone

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
Study Start Date :
Oct 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain measured with numerical rating scale [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    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, MD, PhD, Kuopio University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merja Kokki, MD, PhD, Kuopio University Hospital
    ClinicalTrials.gov Identifier:
    NCT02575677
    Other Study ID Numbers:
    • KUH26062012
    First Posted:
    Oct 15, 2015
    Last Update Posted:
    Apr 12, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merja Kokki, MD, PhD, Kuopio University Hospital
    labor pain
    oxycodone
    Additional relevant MeSH terms:
    Labor Pain
    Oxycodone

    Study Results

    No Results Posted as of Apr 12, 2017