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Safety of Epidural Fentanyl and Adrenalin During Childbirth

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ClinicalTrials.gov Identifier: NCT00685672
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : March 30, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

Condition or disease Intervention/treatment Phase
Pregnancy Pain Drug: adrenalin Drug: placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth
Study Start Date : August 2008
Primary Completion Date : January 2016
Study Completion Date : January 2016


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Plasma concentration of fentanyl [ Time Frame: hours ]

Secondary Outcome Measures :
  1. length of active labor [ Time Frame: hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by Leiv Arne Rosseland, 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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
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
Vasoconstrictor Agents