MedTrace Logo

Intravenous Paracetamol for Postoperative Pain

NCT02248493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-03-06

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Recovery of Function
  • Child

Interventions

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.

Sponsors & Collaborators

  • Lithuanian University of Health Sciences

    lead OTHER

Principal Investigators

  • Danguole C Rugyte, MD. PhD · Lithuanian University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Lithuania

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02248493 on ClinicalTrials.gov