Safety of Epidural Fentanyl and Adrenalin During Childbirth

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685672
• Other study ID #: edaadr-07
• Secondary ID: EUDRACT 2007-000
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2008
• Last updated: March 29, 2016
• Start date: August 2008
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women at term in active labor

Exclusion Criteria:

• age below 18 years

• BMI > 40

• drug hypersensitivity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pregnancy

Intervention

Drug:
• adrenalin
adrenalin 2 microgram pr ml placebo
• placebo
Saline instead of adrenaline in the epidural mixture

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog
Norway	Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of fentanyl		hours	Yes
Secondary	length of active labor		hours	Yes