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

This study has been completed.
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01016821
First received: November 19, 2009
Last updated: January 10, 2011
Last verified: January 2011

November 19, 2009
January 10, 2011
November 2009
December 2010   (final data collection date for primary outcome measure)
The efficacy and safety of oxycodone in labor pain [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01016821 on ClinicalTrials.gov Archive Site
The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Labor Pain
Drug: Oxycodone
Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes
Oxycodone, labour pain
Intervention: Drug: Oxycodone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01016821
KUH5070213, 2009-013469-25
Yes
Merja Kokki, PhD, Kuopio University Hospital, Department of Anaesthesiology and Intensive Care
Kuopio University Hospital
Not Provided
Principal Investigator: Merja Kokki, PhD Kuopio University Hospital
Kuopio University Hospital
January 2011

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