Morphine intravenous vs. Acetaminophen intravenous in neonates and young infants undergoing major non-cardiac surgery.

Completed

• Conditions: Analgesie; Nociception; pain

• Registration Number: NL-OMON31857
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Potential participants will be term infants (>35 wks of gestational age) less than one year of age, who are admitted to the ICU after major thoracic (non-cardiac) or abdominal surgery.

Exclusion Criteria

- Withdrawal of informed consent
- Neonates with neurological, renal insufficiency, or hepatic dysfunction.
- Chronic (more than one day) opioid or psychotropic drug (e.g. antiepileptics, benzodiazepines, antidepressants) exposure pre- or postnatally
- Opioid exposure <24 hrs before surgery
- Receiving ECMO-therapy.
- Known allergy / intolerance for acetaminophen or morphine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Body weight corrected morphine dose needed in the first 48 hrs postsurgery.<br /><br>Mean morphine dose needed will be 30% less in the infants receiving<br /><br>acetaminophen IV as compared to the patients who received only morphine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>VAS and COMFORT scale area under the curve.<br /><br>Occurence of side-effects.<br /><br>Body part activity scores.<br /><br>Saliva cortisol levels.<br /><br>Urine for medication metabolism and renal clearance.<br /><br>Blood samples for PK-PD data.<br /><br>Pharmacogenetic markers (e.g. CYP polymorphisms)</p><br>