Safety of Epidural Fentanyl and Adrenalin During Childbirth

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Pain; Pregnancy

Treatments: Drug: placebo; Drug: adrenalin

Study type: Interventional

Funder types: Other

Identifiers

NCT00685672

edaadr-07

EUDRACT 2007-000322-52

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women at term in active labor

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

adrenalin

Treatment:

Drug: adrenalin

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo