Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: December 2011

Intervention(s) in this Clinical Trial

• Drug: Oxycodone
  • Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes

Arms, Groups and Cohorts in this Clinical Trial

• Other: Oxycodone, labour pain

Primary Measures

• The efficacy and safety of oxycodone in labor pain
  • Time Frame: 24 hours
    Safety Issue?: Yes

Secondary Measures

• The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth
  • Time Frame: 24 hours
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kuopio University Hospital

Overall Clinical Trial Officials and Contacts

Overall Contact: Merja Laisalmi-Kokki, PhD + 358 44 7174764 merja.laisalmi-kokki@kuh.fi

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01016821

Study ID Number: KUH5070213

ClinicalTrials.gov Identifier: NCT01016821

Health Authority: Finland: Finnish Medicines Agency