Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

N/ATerminatedNCT00200590

Nantes University Hospital30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

acetaminophen and nalbuphineDRUG

acetaminophen and morphineDRUG

acetaminophen and reduced dosage of prostaglandinDRUG

Eligibility

Sex: ALLMax age: 28 Days

Medical Language ↔ Plain English

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

Locations (1)

Nantes University Hospital

Nantes, France

Outcomes

Primary Outcomes

Pain score

Time frame: before inclusion and at 8 hours (H8), H24, H48, H72

Secondary Outcomes

Incidence of apnea

Need for mechanical ventilation

Incidence of fever

Pattern of feeding (oral, nasogastric [NG] tubing, parenteral nutrition)

Data from ClinicalTrials.gov

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