Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

This study has been terminated.
(More important number of SAE in one arms)
Information provided by:
Nantes University Hospital Identifier:
First received: September 12, 2005
Last updated: April 18, 2008
Last verified: April 2008
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
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: Open Label
Primary Purpose: Treatment
Official Title: Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Resource links provided by NLM:

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)

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

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
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Please refer to this study by its identifier: NCT00200590

Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Véronique Gournay, MD Nantes UH
  More Information

No publications provided

Responsible Party: Dr Véronique Gournay, CHU de Nantes Identifier: NCT00200590     History of Changes
Other Study ID Numbers: BRD/03/7-D
Study First Received: September 12, 2005
Last Updated: April 18, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 27, 2015