Safety of Epidural Fentanyl and Adrenalin During Childbirth

Phase 4

Completed

• Conditions: Pregnancy; Pain
• Interventions: Drug: adrenalin; Drug: placebo

• Registration Number: NCT00685672
• Lead Sponsor: Oslo University Hospital

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 Timeline

• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-28
• Study Start: 2008-08
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Pregnant women at term in active labor

Exclusion Criteria

• age below 18 years
• BMI > 40
• drug hypersensitivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	adrenalin	adrenalin
2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Plasma concentration of fentanyl	hours

Secondary Outcome Measures

Name	Time	Method
length of active labor	hours

Trial Locations

Locations (2)

Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway

Akershus University Hospital; 🇳🇴 Lørenskog, Norway