Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy (Oksiobs)
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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 |
- The efficacy and safety of oxycodone in labor pain [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- 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 |
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 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 May 22, 2013