Safety of Epidural Fentanyl and Adrenalin During Childbirth
Information source: Rikshospitalet-Radiumhospitalet HF
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy; Pain
Intervention: adrenalin (Drug); placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Rikshospitalet-Radiumhospitalet HF Official(s) and/or principal investigator(s):
Harald Breivik, PhD MD, Study Director, Affiliation: Division of Anaesthesia and Intensive Care Medicine, Rikshospitalet University Hospital, Oslo, Norway
Overall contact:
Leiv Arne Rosseland, PhD MD, Phone: 47-2307-3700, Email: l.a.rosseland@medisin.uio.no
Summary
Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural
solution given to women in childbirth
Clinical Details
Official title: Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Plasma concentration of fentanyl
Secondary outcome: length of active labor
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Pregnant women at term in active labor
Exclusion Criteria:
- age below 18 years
- BMI > 40
- drug hypersensitivity
Locations and Contacts
Leiv Arne Rosseland, PhD MD, Phone: 47-2307-3700, Email: l.a.rosseland@medisin.uio.no
Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital, Oslo 0027, Norway
Additional Information
Starting date: August 2008
Ending date: June 2010
Last updated: May 23, 2008
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