Intravenous Paracetamol for Postoperative Pain (IVPARACET)

Lithuanian University of Health Sciences

Status and phase: Completed; Phase 4

Conditions: Child; Recovery of Function; Pain, Postoperative

Treatments: Drug: Tramadol; Drug: Ketoprofen; Drug: Paracetamol; Drug: Placebo (for paracetamol); Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02248493

BEC-MF-10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

paracetamol and ketoprofen

Experimental group

Description:

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.

Treatment:

Drug: Morphine

Drug: Paracetamol

Drug: Ketoprofen

Drug: Tramadol

placebo and ketoprofen

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (for paracetamol)

Drug: Morphine

Drug: Ketoprofen

Drug: Tramadol