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Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy

NCT03444636 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2020-05-28

No results posted yet for this study

Summary

The study was performed in patients aged 6-18 years after the Ravitch procedure and thoracotomy. The primary aim of the study was to evaluate the efficacy and safety of pain control provided by the multimodal approach that involves the continuous infusion ropivacaine with fentanyl vs. bupivacaine with fentanyl through thoracic epidural catheter. Secondary aims were to identify the determinants of acute post-operative pain at rest, during deep breathing and coughing.

Conditions

  • Pain, Postoperative
  • Surgery, Thoracic

Interventions

DRUG

Ropivacaine/Fentanyl

Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr

DRUG

Bupivacaine/Fentanyl

Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr

Sponsors & Collaborators

  • National Institute for Tuberculosis and Lung Diseases, Poland

    lead OTHER

Principal Investigators

  • Lucyna Tomaszek, PhD · National Institute for Tuberculosis and Lung Diseases, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-02
Primary Completion
2017-03-14
Completion
2017-03-14

Countries

  • Poland

Study Locations

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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 NCT03444636 on ClinicalTrials.gov