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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

September 12, 2005
April 18, 2008
December 2003
July 2006   (final data collection date for primary outcome measure)
Pain score [ Time Frame: before inclusion and at 8 hours (H8), H24, H48, H72 ]
Pain score before inclusion and at H8, H24, H48, H72
Complete list of historical versions of study NCT00200590 on ClinicalTrials.gov Archive Site
  • Incidence of apnea
  • Need for mechanical ventilation
  • Incidence of fever
  • Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)
  • Incidence of apnea
  • need for mechanical ventilation
  • incidence of fever
  • pattern of feeding (oral, NG tubing, perenteral nutrition)
Not Provided
Not Provided
 
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Drug: acetaminophen and nalbuphine
  • Drug: acetaminophen and morphine
  • Drug: acetaminophen and reduced dosage of prostaglandin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
up to 28 Days
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00200590
BRD/03/7-D
Not Provided
Dr Véronique Gournay, CHU de Nantes
Nantes University Hospital
Not Provided
Principal Investigator: Véronique Gournay, MD Nantes UH
Nantes University Hospital
April 2008

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