Safety of Epidural Fentanyl and Adrenalin During Childbirth

Oslo University Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pregnancy Pain

Interventions

adrenalinDRUG

adrenalin 2 microgram pr ml placebo

placeboDRUG

Saline instead of adrenaline in the epidural mixture

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women at term in active labor Exclusion Criteria: * age below 18 years * BMI \> 40 * drug hypersensitivity

Locations (2)

Akershus University Hospital

Lørenskog, Norway

Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Plasma concentration of fentanyl

Time frame: hours

Secondary Outcomes

length of active labor

Time frame: hours

Data from ClinicalTrials.gov

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