Morphine or paracetamol as pain medication in children after open heart surgery

Phase 1

• Conditions: congenital cardiac defects; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2015-001835-20-BE
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-22
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Informed consent,
Neonate / infant aged 0-36 months,
Cardiac surgery with the use of CPB.

Are the trial subjects under 18? yes
Number of subjects for this age range: 208
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

No informed consent
Known allergy to or intolerance for paracetamol or morphine,
Administration of opioids in the 24 hours prior to surgery.
Hepatic dysfunction defined as three times the reference value of ALAT/ASAT.
Renal insufficiency defined as Pediatric RIFLE category - injury, defined as estimated creatinine clearance reduced by 50% and urine output <0.5 ml/kg/h for 16 hours.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified