Safety of Epidural Fentanyl and Adrenalin During Childbirth

This study is ongoing, but not recruiting participants.
University Hospital, Akershus
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital Identifier:
First received: May 21, 2008
Last updated: November 7, 2013
Last verified: November 2013

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 ]

Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (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
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
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

No publications provided

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: November 7, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
labor analgesia

Additional relevant MeSH terms:
Epinephryl borate
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
Adrenergic alpha-Agonists
Vasoconstrictor Agents
Cardiovascular Agents
Adjuvants, Anesthesia
Central Nervous System Agents
Central Nervous System Depressants
Sensory System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on April 16, 2014