Safety of Epidural Fentanyl and Adrenalin During Childbirth | NCT00685672

Studies
Safety of Epidural Fentanyl and Adrenalin During Childbirth

NCT00685672

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Mar 30, 2016Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Pregnancy
Pain

Interventions

adrenalin
placebo

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRACT 2007-000322-52

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

May 21, 2008

First Submission Date that Met QC Criteria

May 23, 2008

First Posted Date

May 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2016

Last Update Posted Date

Mar 30, 2016Estimated

Name	Class
University Hospital, Akershus	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	adrenalin	Drug: adrenalin
2	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
adrenalin	Drug	adrenalin 2 microgram pr ml placebo	1
placebo

Measure	Description	Time Frame
Plasma concentration of fentanyl		hours

Measure	Description	Time Frame
length of active labor		hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women at term in active labor

Exclusion Criteria:

age below 18 years
BMI > 40
drug hypersensitivity

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vegard Dahl, PhD MD	Dep of Anesethesiology, Akershus University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akershus University Hospital		Lørenskog			Norway
Division of Anaesthesiology and Intensive Care Medicine, Rikshospitalet University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29943508	Derived	Haidl F, Rosseland LA, Spigset O, Dahl V. Effects of Adrenaline on maternal and fetal fentanyl absorption in epidural analgesia: A randomized trial. Acta Anaesthesiol Scand. 2018 Oct;62(9):1267-1273. doi: 10.1111/aas.13175. Epub 2018 Jun 25.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals