Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy (Oksiobs)

January 10, 2011 updated by: Kuopio University Hospital

The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain

Childbirth is one of the most painful events that a woman is likely to experience, and thus is a major concern for most parturient. Severe pain releases stress mediators and may thus compromise fetus well-being if placental perfusion is decreased. Epidural analgesia is the golden standard for the management of severe labor pain. However, it could not always be used both due the parturient related factors and the organizational reasons.However, the knowledge on safety and efficacy of oxycodone involving mother, fetus and newborn is limited.

Aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain healthy parturients. Secondly, to measure parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

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
      • Kuopio, Finland, 70800
        • 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 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Labouring healthy women
  • Early labour
  • Age 18-45 years

Exclusion Criteria:

  • Sleep apnea or other central deficit affecting breathing
  • Pulmonary insufficiency
  • Liver of kidney insufficiency
  • Use of mono amine oxidase medication
  • Thyroid, pituitary insufficiency
  • Paralytic ileus
  • Other contraindication specified by the investigator

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Oxycodone, labour pain
Drug: Oxycodone
Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The efficacy and safety of oxycodone in labor pain
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Kuopio University Hospital

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

November 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (ESTIMATE)

November 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5070213
  • 2009-013469-25 (OTHER: Eudra CT number)

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.

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