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NCT00200590 Clinical Trial

Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Pain Clinical Trial

Official title:
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00200590
Other study ID # BRD/03/7-D
Secondary ID
Status Terminated
Phase N/A
First received September 12, 2005
Last updated April 18, 2008
Start date December 2003
Est. completion date July 2006

Study information
Verified date April 2008
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group N/A to 28 Days
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• acetaminophen and nalbuphine

• acetaminophen and morphine

• acetaminophen and reduced dosage of prostaglandin

Locations
Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score before inclusion and at 8 hours (H8), H24, H48, H72
Secondary Incidence of apnea
Secondary Need for mechanical ventilation
Secondary Incidence of fever
Secondary Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)
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