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OpenTrials
Completed

NCT Number: NCT01016821

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

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70800, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes

Primary outcomes

  1. The efficacy and safety of oxycodone in labor pain

    Time frame: 24 hours

Secondary outcomes

  1. The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

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

Acronym: Oksiobs

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 20, 2009
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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