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Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

NCT ID: NCT00200590

Last Updated: 2008-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-07-31

Brief Summary

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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

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Conditions

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Pain

Keywords

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prostaglandin analgesia congenital heart defect induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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acetaminophen and nalbuphine

Intervention Type DRUG

acetaminophen and morphine

Intervention Type DRUG

acetaminophen and reduced dosage of prostaglandin

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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CHU de Nantes

Principal Investigators

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Véronique Gournay, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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BRD/03/7-D

Identifier Type: -

Identifier Source: org_study_id