Safety of Epidural Fentanyl and Adrenalin During Childbirth - Full Text View

Sponsor:	Rikshospitalet HF
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00685672

Purpose

Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

Condition	Intervention	Phase
Pregnancy Pain	Drug: adrenalin Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth

Resource links provided by NLM:

Drug Information available for: Epinephrine bitartrate Epinephrine Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

Plasma concentration of fentanyl [ Time Frame: hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

length of active labor [ Time Frame: hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental adrenalin	Drug: adrenalin adrenalin 2 microgram pr ml placebo
2: Placebo Comparator placebo	Drug: placebo Saline instead of adrenaline in the epidural mixture

Detailed Description:

Healthy women with indication for labor epidural at the Labor Clinic, Rikshospitalet University Hospital, may be included. A randomized, placebocontrolled, double blind,comparison of epidural with and without adrenalin. Outcome: Length of birth, quality of pain relief, total amount of epidural solution injected, and plasma concentration of fentanyl.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pregnant women at term in active labor

Exclusion Criteria:

age below 18 years
BMI > 40
drug hypersensitivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685672

Locations

Norway
Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital
Oslo, Norway, 0027

Sponsors and Collaborators

Rikshospitalet HF

Investigators

Study Director:

Harald Breivik, PhD MD

Division of Anaesthesia and Intensive Care Medicine, Rikshospitalet University Hospital, Oslo, Norway

More Information

No publications provided

Responsible Party:	University of Oslo ( Harald Breivik, Professor, University of Oslo, Norway )
Study ID Numbers:	edaadr-07, EUDRACT 2007-000322-52
Study First Received:	May 21, 2008
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00685672 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Rikshospitalet HF:

labor analgesia
fentanyl
epinephrine

Additional relevant MeSH terms:

Respiratory System Agents
Fentanyl
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Adrenergic Agonists
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Analgesics
Epinephrine
Analgesics, Opioid
Anesthetics, Intravenous

Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Sympathomimetics
Anti-Asthmatic Agents
Central Nervous System Depressants
Narcotics
Cardiovascular Agents
Pharmacologic Actions
Adjuvants, Anesthesia
Mydriatics
Anesthetics, General
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010