Major surgery when the use of paracetamol is required for pain release
Conditions
Interventions
Trade Name: Perfusalgan
Product Name: Perfusalgan
Pharmaceutical Form: Intravenous infusion
Trade Name: Lysomucil
Product Name: Lysomucil
Pharmaceutical Form: Intravenous infusion
Sponsors
Cliniques Universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provided signed written informed consent. 2. Boys or girls 2 to 8 years old 3. Patients after major surgery such as cardiac, orthopedic or digestive surgery whereacetaminophen is used in pain management or patients who require acetaminophentreatment for at least 3 days. 4. Nutritional status based on weight, height and skin fold thickness within the normal limits(as described on the growth curves given on the CDC's website :HTTP://www.cdc.gov/nchs/about/major/nhanes/growthcharts/datafiles.htm)5. The following laboratory parameters within the normal limitsa) non-conjugated serum bilirubin calculated with the following formula SNCB = STB – SCB where : SNCB = non conjugated serum bilirubin in mg/dLSTB = total serum bilirubin (nl : 0,3 à 1,2 mg/dL) SCB = conjugated serum bilirubin (nl =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other serious illness or medical condition including:– Infection requiring systemic anti-infective therapy,– Any medical condition that might be aggravated by treatment or which couldn’t be controlled 2. Psychological, familial or sociological conditions which don’t allow medical follow-upand/or compliance with the study protocol. 3. Any hepatic disease which could lead to abnormal hepatic function 4. Any renal disease which could lead to abnormal renal function. 5. Inadequate renal function defined by a creatinine clearance < 60 mL/min Creatinine clearance is calculated using the Schwartz formula CLCR = (k x h)/SCRwhere :h = height in cmCLCR = creatinine clearance in ML/min/1.73m2k = 0,55 for children age 2-12SCR = serum creatinine in mg/dL6. Inadequate liver function defined by ALT/AST superior to twice ULN (upper limit normal)and INR prolonged 7. Prior allergic reaction to acetaminophen 8. Patients who require treatment with strong inhibitors of UGT1A1, including phenobarbital(gardenal® and mysoline®) and phenytoin (dyphantoïne® and épanutine®). 9. Patients who require treatment with activators of CYP2E1 and CYP1A2, including izoniazid(nicotibine®), insulin and omeprazole (docomépra®, logastric®, losec®, oméprasol®,omépratop® and sedacid®). 10. Patients who have received antipyretic drugs in the last 72 hours. 11. Participation in a clinical study with an investigational agent or device within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : Study the metabolism and the pharmacokinetics of acetaminophenadministered at maximal doses in post-op pediatric patients with relation to UDPglucuronyltransferase 1A1 (UGT1A1), cytochrome P450 2E1 and 1A2 (CYP2E1 and CYP1A2),and glutathion-S-transferase M1, P1 and T1 (GSTM1, GSTP1 and GSTT1) polymorphisms.;Secondary Objective: Rationalize the empiric use of N-acetylcysteine to prevent acute liver failure.;Primary end point(s): Safety of acetaminophen administered at maximal doses in post-op pediatric patients | — |
Countries
Belgium
Outcome results
None listed