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Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

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ClinicalTrials.gov Identifier: NCT00200590
Recruitment Status : Terminated (More important number of SAE in one arms)
First Posted : September 20, 2005
Last Update Posted : April 21, 2008
Information provided by:

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

Condition or disease Intervention/treatment
Pain Drug: acetaminophen and nalbuphine Drug: acetaminophen and morphine Drug: acetaminophen and reduced dosage of prostaglandin

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analgesic Strategies in Newborns Receiving Prostaglandin Therapy
Study Start Date : December 2003
Primary Completion Date : July 2006
Study Completion Date : July 2006
Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. Incidence of apnea
  2. Need for mechanical ventilation
  3. Incidence of fever
  4. Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)

Eligibility Criteria

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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

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

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
ClinicalTrials.gov Identifier: NCT00200590     History of Changes
Other Study ID Numbers: BRD/03/7-D
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 21, 2008
Last Verified: April 2008

Keywords provided by Nantes University Hospital:

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