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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 April 27, 2016