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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:
ClinicalTrials.gov Identifier:
NCT00200590
First Posted: September 20, 2005
Last Update Posted: April 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nantes University Hospital
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Véronique Gournay, CHU de Nantes
ClinicalTrials.gov Identifier: NCT00200590     History of Changes
Other Study ID Numbers: BRD/03/7-D
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: April 21, 2008
Last Verified: April 2008

Keywords provided by Nantes University Hospital:
prostaglandin
analgesia
congenital
heart
defect
induced

Additional relevant MeSH terms:
Morphine
Nalbuphine
Acetaminophen
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Narcotic Antagonists