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

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Oxycodone
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Oxycodone, Labour pain, Pregnancy, Pregnant women

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Oxycodone, labour pain

Arm Description

Outcomes

Primary Outcome Measures

The efficacy and safety of oxycodone in labor pain

Secondary Outcome Measures

The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth

Full Information

First Posted
November 19, 2009
Last Updated
January 10, 2011
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01016821
Brief Title
Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy
Acronym
Oksiobs
Official Title
The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Oxycodone, Labour pain, Pregnancy, Pregnant women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone, labour pain
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes
Primary Outcome Measure Information:
Title
The efficacy and safety of oxycodone in labor pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merja Kokki, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70800
Country
Finland

12. IPD Sharing Statement

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

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