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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02575677
Recruitment Status : Unknown
Verified March 2017 by Merja Kokki, Kuopio University Hospital.
Recruitment status was:  Recruiting
First Posted : October 15, 2015
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
Admescope Ltd
Information provided by (Responsible Party):
Merja Kokki, Kuopio University Hospital

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
Labor Pain Other: oxycodone

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
Study Start Date : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)


Biospecimen Retention:   Samples Without DNA
venous blood for the analysis of oxycodone


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parturients who are in early labor and need some pain medication.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575677


Contacts
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Contact: Merja Kokki, PhD +358-44-7174764
Contact: Hannu Kokki, professor +358503790374 hannu.kokki@uef.fi

Locations
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Finland
Kuopio University Hospital Recruiting
Kuopio, Northern savo, Finland, 70029
Contact: Merja Kokki, PhD    +358447174764      
Sponsors and Collaborators
Kuopio University Hospital
Admescope Ltd
Investigators
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Principal Investigator: Merja Kokki, MD, PhD Kuopio University Hospital

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Responsible Party: Merja Kokki, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT02575677     History of Changes
Other Study ID Numbers: KUH26062012
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merja Kokki, Kuopio University Hospital:
labor pain
oxycodone

Additional relevant MeSH terms:
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Oxycodone
Labor Pain
Obstetric Labor, Premature
Pain
Neurologic Manifestations
Signs and Symptoms
Obstetric Labor Complications
Pregnancy Complications
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents