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: November 7, 2013
Last verified: November 2013
  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:


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

Keywords provided by Oslo University Hospital:
labor analgesia
fentanyl
epinephrine

Additional relevant MeSH terms:
Fentanyl
Epinephrine
Racepinephrine
Epinephryl borate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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
Mydriatics
Sympathomimetics

ClinicalTrials.gov processed this record on September 18, 2014