Safety of Epidural Fentanyl and Adrenalin During Childbirth

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00685672

Collaborator

University Hospital, Akershus (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Pain	Drug: adrenalin Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 adrenalin	Drug: adrenalin adrenalin 2 microgram pr ml placebo
Placebo Comparator: 2 placebo	Drug: placebo Saline instead of adrenaline in the epidural mixture

Arm

Intervention/Treatment

Experimental: 1

adrenalin

Drug: adrenalin

adrenalin 2 microgram pr ml placebo

Placebo Comparator: 2

placebo

Drug: placebo

Saline instead of adrenaline in the epidural mixture

Outcome Measures

Primary Outcome Measures

Plasma concentration of fentanyl [hours]

Secondary Outcome Measures

length of active labor [hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pregnant women at term in active labor

Exclusion Criteria:

age below 18 years
BMI > 40
drug hypersensitivity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akershus University Hospital	Lørenskog		Norway
2	Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital	Oslo		Norway	0027