We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety of Epidural Fentanyl and Adrenalin During Childbirth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685672
First Posted: May 28, 2008
Last Update Posted: March 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital
May 21, 2008
May 28, 2008
March 30, 2016
August 2008
January 2016   (Final data collection date for primary outcome measure)
Plasma concentration of fentanyl [ Time Frame: hours ]
Same as current
Complete list of historical versions of study NCT00685672 on ClinicalTrials.gov Archive Site
length of active labor [ Time Frame: hours ]
Same as current
Not Provided
Not Provided
 
Safety of Epidural Fentanyl and Adrenalin During Childbirth
Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pregnancy
  • Pain
  • Drug: adrenalin
    adrenalin 2 microgram pr ml placebo
  • Drug: placebo
    Saline instead of adrenaline in the epidural mixture
  • Experimental: 1
    adrenalin
    Intervention: Drug: adrenalin
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2016
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women at term in active labor

Exclusion Criteria:

  • age below 18 years
  • BMI > 40
  • drug hypersensitivity
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00685672
edaadr-07
EUDRACT 2007-000322-52
No
Not Provided
Not Provided
Leiv Arne Rosseland, Oslo University Hospital
Oslo University Hospital
University Hospital, Akershus
Study Director: Vegard Dahl, PhD MD Dep of Anesethesiology, Akershus University Hospital
Oslo University Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP