Safety of Epidural Fentanyl and Adrenalin During Childbirth

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00685672

Enrollment

Registered

2008-05-28

Start date

2008-08-31

Completion date

2016-01-31

Last updated

2016-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Pain

Keywords

labor analgesia, fentanyl, epinephrine

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.

Interventions

DRUGadrenalin

adrenalin 2 microgram pr ml placebo

DRUGplacebo

Saline instead of adrenaline in the epidural mixture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Pregnant women at term in active labor

Exclusion criteria

* age below 18 years * BMI \> 40 * drug hypersensitivity

Design outcomes

Primary

Measure	Time frame
Plasma concentration of fentanyl	hours

Secondary

Measure	Time frame
length of active labor	hours

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026