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
Conditions
Sponsors
ErasmusmMC/ Sophia Children Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 b. the incidence of opioid related adverse effects c. average pain scores d. % of time patient is adequately pain free e. body part activity scores f. saliva cortisol levels (as surrogate marker of stress) e. renal clearance of Acetaminophen and glucuronidation and sulphate formation. g. pharmacogenetic markers (e.g. CYP polymorphisms) ;Primary end point(s): Mean morphine dose over 48 h in µg/kg/h | — |
Countries
Netherlands
Outcome results
None listed