Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

This study has been terminated.

(More important number of SAE in one arms)

Sponsor:

Information provided by:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT00200590

First received: September 12, 2005

Last updated: April 18, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

April 18, 2008

Start Date ^ICMJE

December 2003

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain score [ Time Frame: before inclusion and at 8 hours (H8), H24, H48, H72 ]

Original Primary Outcome Measures ^ICMJE

Pain score before inclusion and at H8, H24, H48, H72

Change History

Complete list of historical versions of study NCT00200590 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of apnea
Need for mechanical ventilation
Incidence of fever
Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)

Original Secondary Outcome Measures ^ICMJE

Incidence of apnea
need for mechanical ventilation
incidence of fever
pattern of feeding (oral, NG tubing, perenteral nutrition)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Official Title ^ICMJE

Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 28 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00200590

Other Study ID Numbers ^ICMJE

BRD/03/7-D

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr Véronique Gournay, CHU de Nantes

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Véronique Gournay, MD

Nantes UH

Information Provided By

Nantes University Hospital

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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