Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Not Applicable

Terminated

• Conditions: Pain

• Registration Number: NCT00200590
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-18
• Last Update Posted: 2008-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score	before inclusion and at 8 hours (H8), H24, H48, H72

Secondary Outcome Measures

Name	Time	Method
Incidence of apnea
Need for mechanical ventilation
Incidence of fever
Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France