NCT02248493

Intravenous Paracetamol for Postoperative Pain

The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Lithuanian University of Health Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pain, Postoperative
• Recovery of Function
• Child

Interventions

Type	Name	Description
DRUG	Paracetamol
DRUG	Placebo (for paracetamol)
DRUG	Ketoprofen
DRUG	Tramadol	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.
DRUG	Morphine	administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2014-09-25
• Last updated: 2017-03-06

Locations

1 site across 1 country: Lithuania