Safety of Epidural Fentanyl and Adrenalin During Childbirth

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Oslo University Hospital
University Hospital, Akershus
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital Identifier:
First received: May 21, 2008
Last updated: April 22, 2015
Last verified: April 2015
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 2015
Estimated Primary Completion Date: July 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00685672

Contact: Leiv Arne Rosseland, PhD MD 47-2307-3700
Contact: Vegard Dahl, PhD MD +4791674604

Akershus University Hospital Recruiting
Lørenskog, Norway
Contact: Vegard Dahl, MD PhD    91674604   
Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital Not yet recruiting
Oslo, Norway, 0027
Contact: Øyvind Skraastad, PhD MD    47-2307-3700   
Contact: Harald Breivik, PhD MD    47-2307-3700   
Principal Investigator: Leiv Arne Rosseland, PhD MD         
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: April 22, 2015
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
labor analgesia

Additional relevant MeSH terms:
Epinephryl borate
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sympathomimetics processed this record on November 25, 2015