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Safety of Epidural Fentanyl and Adrenalin During Childbirth

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00685672
First received: May 21, 2008
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

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: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
adrenalin
 Drug: adrenalin
adrenalin 2 microgram pr ml placebo
Placebo Comparator: 2
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
Akershus University Hospital
Lørenskog, Norway
Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Investigators
Study Director: Vegard Dahl, PhD MD Dep of Anesethesiology, Akershus University Hospital
  More Information

No publications provided

Responsible Party: Leiv Arne Rosseland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00685672     History of Changes
Other Study ID Numbers: edaadr-07, EUDRACT 2007-000322-52
Study First Received: May 21, 2008
Last Updated: September 28, 2012
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
labor analgesia
fentanyl
epinephrine

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Fentanyl
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
 Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Adjuvants, Anesthesia
Central Nervous System Agents
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 16, 2013