Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy (Oksiobs)
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 Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain|
- The efficacy and safety of oxycodone in labor pain [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||November 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Oxycodone, labour pain||
Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes