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: September 28, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 21, 2008

Last Updated Date

September 28, 2012

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Plasma concentration of fentanyl [ Time Frame: hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00685672 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

length of active labor [ Time Frame: hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety of Epidural Fentanyl and Adrenalin During Childbirth

Official Title ^ICMJE

Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth

Brief Summary

Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pregnancy
Pain

Intervention ^ICMJE

Drug: adrenalin
adrenalin 2 microgram pr ml placebo
Drug: placebo
Saline instead of adrenaline in the epidural mixture

Study Arm (s)

Experimental: 1
adrenalin

Intervention: Drug: adrenalin
Placebo Comparator: 2
placebo

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Pregnant women at term in active labor

Exclusion Criteria:

age below 18 years
BMI > 40
drug hypersensitivity

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00685672

Other Study ID Numbers ^ICMJE

edaadr-07, EUDRACT 2007-000322-52

Has Data Monitoring Committee

Responsible Party

Leiv Arne Rosseland, Oslo University Hospital

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

University Hospital, Akershus

Investigators ^ICMJE

Study Director:

Vegard Dahl, PhD MD

Dep of Anesethesiology, Akershus University Hospital

Information Provided By

Oslo University Hospital

Verification Date

September 2012

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

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