Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

This study has been terminated.

( More important number of SAE in one arms )

First Received: September 12, 2005 Last Updated: April 18, 2008 History of Changes

Sponsor:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200590

Purpose

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

Condition	Intervention
Pain	Drug: acetaminophen and nalbuphine Drug: acetaminophen and morphine Drug: acetaminophen and reduced dosage of prostaglandin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Resource links provided by NLM:

Drug Information available for: Nalbuphine Nalbuphine hydrochloride Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	December 2003
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200590

Locations

France
Nantes University Hospital
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Véronique Gournay, MD

Nantes UH

More Information

No publications provided

Responsible Party:	CHU de Nantes ( Dr Véronique Gournay )
Study ID Numbers:	BRD/03/7-D
Study First Received:	September 12, 2005
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00200590 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

prostaglandin
analgesia
congenital

heart
defect
induced

Additional relevant MeSH terms:

Nalbuphine
Physiological Effects of Drugs
Narcotic Antagonists
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Acetaminophen
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 09, 2009