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

Labor Pain Clinical Trial

— Oksiobs  

Official title:

The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016821
• Other study ID #: KUH5070213
• Secondary ID: 2009-013469-25
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: January 10, 2011
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy and safety of oxycodone in labor pain		24 hours	Yes
Secondary	The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth		24 hours	Yes