Clinical Trial: Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary:
Sponsor: Kuopio University Hospital
Current Primary Outcome: The efficacy and safety of oxycodone in labor pain [ Time Frame: 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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: Same as current
Information By: Kuopio University Hospital
Dates:
Date Received: November 19, 2009
Date Started: November 2009
Date Completion:
Last Updated: January 10, 2011
Last Verified: January 2011