Intravenous Paracetamol for Postoperative Pain (IVPARACET)

The purpose of this study is to define if intravenous paracetamol may improve analgesia and outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively. Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and adolescents following surgery.

Patients aged 1-18 years undergoing general, plastic or orthopedic surgery with expected moderate to severe pain at least for 24 hours postoperatively, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. At the end of surgical procedure, at skin closure, all patients are given 1,5 mg/kg intravenous ketoprofen and repeated every 8 hours up till 4,5 mg/kg/24 h. Patients in paracetamol group are additionally given the first dose of IV paracetamol 20 mg/kg and repeated 6 and 20 hours postoperatively up till 60 mg/kg/24 h. Patients in the placebo group are given 0.9% sodium chloride 2 ml/kg IV and repeated 6 and 20 hours postoperatively. After surgery optional rescue analgesia is given on patient request: either tramadol in a dose of 2 mg/kg (up till 4 mg/kg/24h), either patient-controlled analgesia (PCA) with morphine, as indicated according to the standard of care. Patients are evaluated up till 24 hours postoperatively. After that patients are followed up as long as indicated per standard of care.

Pain, Postoperative, Paracetamol, Administration, Intravenous, Anti-Inflammatory Agents, Non-Steroidal, Child, Adolescent

paracetamol 20 mg/kg (1% 2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter. ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.

0.9% sodium chloride (2 ml/kg) IV at the end of surgery 6 and 20 hours thereafter. ketoprofen 1.5 mg/kg IV at the end of surgery 8 and 16 hours thereafter. tramadol 2 mg/kg IV on patient request up til 4 mg/kg or PCA morphine during 24 hours postoperatively.

Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses. No other opioid is given to these patients.

administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.

Inclusion Criteria: Patients 1-18 years of age, undergoing general, plastic or orthopedic surgery with expected median to severe pain postoperatively. physical status of the patient corresponding to American Society of Anesthesiologists (ASA) class 1 or 2 Signed written informed consent by parents/official caregivers. Exclusion Criteria: Allergy to paracetamol, ketoprofen, tramadol, morphine or any NSAID oncologic disease central nervous system disease renal dysfunction hepatic dysfunction bronchial asthma ulcer(s) in gastrointestinal system hemorrhagic diathesis chronic use of NSAIDs chronic use of opioids chronic use of anticoagulants female patient is known to be pregnant

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