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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxycodone, labour pain

Group Type OTHER

Oxycodone

Intervention Type DRUG

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

Interventions

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Oxycodone

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No