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

• Sponsor: Kuopio University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01016821
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 13
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Oxycodone	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Oxycodone, labour pain	Drug: Oxycodone; Intravenous, 1 mg, 5 times, in every 5 minutes, duration of drug administration 25 minutes

Outcome Measures

Primary Outcome Measures

1. The efficacy and safety of oxycodone in labor pain [24 hours]

Secondary Outcome Measures

1. The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Kuopio University Hospital	Kuopio		Finland	70800

Sponsors and Collaborators

• Kuopio University Hospital

Investigators

• Principal Investigator: Merja Kokki, PhD, Kuopio University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01016821
• Other Study ID Numbers: KUH5070213; 2009-013469-25
• First Posted: Nov 20, 2009
• Last Update Posted: Jan 11, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Oxycodone; Labour pain; Pregnancy; Pregnant women
• Additional relevant MeSH terms: Labor Pain; Oxycodone

Study Results

No Results Posted as of Jan 11, 2011