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Safety of Epidural Fentanyl and Adrenalin During Childbirth

This study has been completed.
University Hospital, Akershus
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital Identifier:
First received: May 21, 2008
Last updated: March 29, 2016
Last verified: March 2016
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

Condition Intervention Phase
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:

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 ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: adrenalin
adrenalin 2 microgram pr ml placebo
Placebo Comparator: 2
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.

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

Inclusion Criteria:

  • Pregnant women at term in active labor

Exclusion Criteria:

  • age below 18 years
  • BMI > 40
  • drug hypersensitivity
  Contacts and Locations
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Please refer to this study by its identifier: NCT00685672

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
Study Director: Vegard Dahl, PhD MD Dep of Anesethesiology, Akershus University Hospital
  More Information

Responsible Party: Leiv Arne Rosseland, Professor, Oslo University Hospital Identifier: NCT00685672     History of Changes
Other Study ID Numbers: edaadr-07  EUDRACT 2007-000322-52 
Study First Received: May 21, 2008
Last Updated: March 29, 2016
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
labor analgesia

Additional relevant MeSH terms:
Epinephryl borate
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on October 21, 2016