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

Kuopio University Hospital

Status: Completed

Conditions: Labor Pain

Treatments: Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT01016821

2009-013469-25 (Other Identifier)

KUH5070213

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Oxycodone, labour pain

Other group

Treatment:

Drug: Oxycodone