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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01016821
Acronym
Oksiobs
Enrollment
15
Registered
2009-11-20
Start date
2009-11-30
Completion date
2010-12-31
Last updated
2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Oxycodone, Labour pain, Pregnancy, Pregnant women

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.

Interventions

DRUGOxycodone

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

Sponsors

Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
The efficacy and safety of oxycodone in labor pain24 hours

Secondary

MeasureTime frame
The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth24 hours

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026