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Trial record 30 of 683 for:    OXYCODONE

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

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: NCT01016821
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
Kuopio University Hospital

Tracking Information
First Submitted Date  ICMJE November 19, 2009
First Posted Date  ICMJE November 20, 2009
Last Update Posted Date January 11, 2011
Study Start Date  ICMJE November 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
The efficacy and safety of oxycodone in labor pain [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy
Official Title  ICMJE The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Labor Pain
Intervention  ICMJE Drug: Oxycodone
Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes
Study Arms  ICMJE Oxycodone, labour pain
Intervention: Drug: Oxycodone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 19, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01016821
Other Study ID Numbers  ICMJE KUH5070213
2009-013469-25 ( Other Identifier: Eudra CT number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merja Kokki, PhD, Kuopio University Hospital, Department of Anaesthesiology and Intensive Care
Study Sponsor  ICMJE Kuopio University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Merja Kokki, PhD Kuopio University Hospital
PRS Account Kuopio University Hospital
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP