Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Pain

Treatments: Drug: acetaminophen and nalbuphine; Drug: acetaminophen and morphine; Drug: acetaminophen and reduced dosage of prostaglandin

Study type: Interventional

Funder types: Other

Identifiers

NCT00200590

BRD/03/7-D

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)