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

Conditions: Patients after non-cardiac thoracic or abdominal major surgery receive Morphine as pain relief medication whereas this is associated with Morphine related side effects. In these patients a non-opioid drug could be appropriate for postoperative pain relief. Intermittent administration of intravenous Acetaminophen, to young infants up to 48 hrs after major surgery e.g. thoracic and abdominal, will lead to a clinically significant (>30%) morphine sparing effect

Registration Number: EUCTR2007-005619-24-NL

Lead Sponsor: ErasmusmMC/ Sophia Children Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 0

Inclusion Criteria

-Informed consent
-Neonate / child under the age of one year.
-Minimal post conceptual age of 35 weeks.
-Minimal body weight of 1500 grams.
-Major thoracic (non cardiac) or abdominal surgery, including urological surgery.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

-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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to test the hypothesis that intravenous acetaminophen will reduce morphine requirements in postoperative infants significantly (>30%).;Secondary Objective: a. number of patients needing extra Morphine boluses<br>b. the incidence of opioid related adverse effects <br>c. average pain scores<br>d. % of time patient is adequately pain free<br>e. body part activity scores <br>f. saliva cortisol levels (as surrogate marker of stress)<br>e. renal clearance of Acetaminophen and glucuronidation and sulphate formation.<br>g. pharmacogenetic markers (e.g. CYP polymorphisms)<br>;Primary end point(s): Mean morphine dose over 48 h in µg/kg/h

Secondary Outcome Measures