Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00200590

Enrollment

Registered

2005-09-20

Start date

2003-12-31

Completion date

2006-07-31

Last updated

2008-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

prostaglandin, analgesia, congenital, heart, defect, induced

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.

Interventions

DRUGacetaminophen and nalbuphine

DRUGacetaminophen and morphine

DRUGacetaminophen and reduced dosage of prostaglandin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026