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

May 21, 2008
November 7, 2013
August 2008
July 2014   (final data collection date for primary outcome measure)
Plasma concentration of fentanyl [ Time Frame: hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00685672 on ClinicalTrials.gov Archive Site
length of active labor [ Time Frame: hours ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Active, not recruiting
40
August 2014
July 2014   (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
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00685672
edaadr-07, EUDRACT 2007-000322-52
No
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
November 2013

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