Trial intelligence / Profile preview

Multimodal Analgesia in Children After Ravitch Procedure and Thoracotomy

NCT03444636Phase 4

Key facts

Status
Completed
Start
Mar 2015
Primary completion
Mar 2017
Countries
1
Modality
Orthosteric Ligands
Conditions
postoperative pain
01

Overview

Phase 4, randomised trial of ropivacaine in postoperative pain (2 arms). Primary endpoints: Pain intensity scores at rest, Pain intensity scores during deep breathing and 2 more. Started Mar 2015; status: completed.

02

Design

2 arms
Study design
Randomized
  • Ropivacaine/Fentanyl

    Ropivacaine 0.2% + Fentanyl 5 µg/ml continuous epidural infusion.

  • Bupivacaine/Fentanyl

    Bupivacaine 0.125% + Fentanyl 5 µg/ml continuous epidural infusion.

03

Who it enrols

Patients aged 6-18 years undergoing elective thoracic surgery (thoracotomy or Ravitch procedure) with continuous thoracic epidural analgesia. Excludes patients with ASA > III, chronic pain, preoperative opioid use, oncological treatment, impaired verbal communication, or early catheter removal.

04

Endpoints

Primary

  • Pain intensity scores at rest

  • Pain intensity scores during deep breathing

  • Pain intensity scores during coughing

  • Side Effect Occurrence

Secondary

  • Total fentanyl consumption

  • The number of doses of metamizol as a 'rescue drug'

  • The number of nursing interventions undertaken to relive pain > 2/10 pts

  • Patient satisfaction

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