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Trial record 24 of 663 for:    OXYCODONE

The Effect of Oxycodone to the Placental Circulation at Early Labour (oksisynnII)

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ClinicalTrials.gov Identifier: NCT02573831
Recruitment Status : Unknown
Verified March 2017 by Merja Kokki, Kuopio University Hospital.
Recruitment status was:  Recruiting
First Posted : October 12, 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 pain in early labor, however the effect of oxycodone to placental or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor pain in the early phase. The aim of the randomised, double blinded, placebo controlled study was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of oxycodone and the effects to the newborn.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: Oxycodone Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Oxycodone to the Placental Circulation at Early Labour
Study Start Date : February 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed
Drug: Placebo
The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more

Experimental: Oxycodone
The patients are given at first oxycodone 0,05 mg/kg and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more
Drug: Oxycodone
The patients are given at first oxycodone 0,05 mg/kg and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more




Primary Outcome Measures :
  1. placental blood flow [ Time Frame: from zero hours to two hours after the first study drug ]
    Placental blood flow is measured with doppler ultrasound


Secondary Outcome Measures :
  1. uterine arterial flow [ Time Frame: from zero hours to two hours after the first study drug ]
    uterine arterial flow is measured with doppler ultrasound



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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
Criteria

Inclusion Criteria:

  • oxycodone planned for pain relief

    • age 18 years or more
    • Informed consent obtained
    • Full term pregnancy

Exclusion Criteria:

  • No oxycodone planned

    • age less than 18 years
    • No informed consent
    • not full term pregnancy
  • Other contraindication to oxycodone

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): NCT02573831


Contacts
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Contact: Merja Kokki, MD, PhD +358-405853685 merja.kokki@kuh.fi
Contact: Hannu Kokki, professor +358-503790374 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: NCT02573831     History of Changes
Other Study ID Numbers: KUH12012015
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Merja Kokki, Kuopio University Hospital:
labor
pain
oxycodone
placenta
Additional relevant MeSH terms:
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Oxycodone
Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents