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

This study has been completed.
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01016821
First received: November 19, 2009
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Labor Pain
Drug: Oxycodone

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • The efficacy and safety of oxycodone in labor pain [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oxycodone, labour pain Drug: Oxycodone
Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016821

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70800
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Principal Investigator: Merja Kokki, PhD Kuopio University Hospital
  More Information

No publications provided

Responsible Party: Merja Kokki, PhD, Kuopio University Hospital, Department of Anaesthesiology and Intensive Care
ClinicalTrials.gov Identifier: NCT01016821     History of Changes
Other Study ID Numbers: KUH5070213, 2009-013469-25
Study First Received: November 19, 2009
Last Updated: January 10, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
Oxycodone
Labour pain
Pregnancy
Pregnant women

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 14, 2014