Analgesic Strategies in Newborns Receiving Prostaglandin... | NCT00200590

Studies
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

NCT00200590

Sponsor

Nantes University Hospital

Status

Terminated

Last Update Posted

Apr 21, 2008Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

acetaminophen and nalbuphine
acetaminophen and morphine
acetaminophen and reduced dosage of prostaglandin

Countries

France

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

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

More important number of SAE in one arms

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

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

Apr 18, 2008

Last Update Posted Date

Apr 21, 2008Estimated

Description Module

Brief Summary

This is a randomised trial comparing the efficacy of 3 different analgesic strategies in newborns on prostaglandin for ductus dependent congenital heart disease.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score		before inclusion and at 8 hours (H8), H24, H48, H72

Secondary Outcomes

Measure	Description	Time Frame
Incidence of apnea
Need for mechanical ventilation
Incidence of fever

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Full-term newborn
Under one month of age
With ductus dependent congenital heart disease requiring prostaglandin infusion and elevated pain score

Exclusion Criteria:

Contraindication to either morphine, acetaminophen, or nalbuphine
Other painful condition
Poor neurological condition
Cardiac instability requiring urgent surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Véronique Gournay, MD	Nantes UH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes		44093	France

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D000377	Agnosia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
D009266	Nalbuphine
D009020	Morphine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
acetaminophen and nalbuphine	Drug
acetaminophen and morphine	Drug
acetaminophen and reduced dosage of prostaglandin	Drug