Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Condition(s) targeted: Pain

Intervention: acetaminophen and nalbuphine (Drug); acetaminophen and morphine (Drug); acetaminophen and reduced dosage of prostaglandin (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Véronique Gournay, MD, Principal Investigator, Affiliation: Nantes UH

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

Official title: Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: Pain score

Secondary outcome:

Incidence of apnea

Need for mechanical ventilation

Incidence of fever

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

Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.

Criteria:

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

Nantes University Hospital, Nantes 44093, France

Starting date: December 2003
Ending date: July 2006
Last updated: April 18, 2008