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

May 26, 2020 updated by: Lucyna Tomaszek, PhD, RN, National Institute for Tuberculosis and Lung Diseases, Poland

The Efficacy and Safety of Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy - a Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The subjects were randomized to the Ropivacaine/Fentanyl (RF) or Bupivacaine/Fentanyl (BF) group.

To perform a thoracic surgical procedure, all patients were premedicated with midazolam, and then, paracetamol, non-steroidal anti-inflammatory drugs, fentanyl, propofol, pancuronium or rocuronium (in children < 10 years old) and suprane were used to introduce and maintain the anesthesia. Thoracic epidural catheters were placed following induction of anesthesia and endotracheal intubation.

Intraoperative analgesia was introduced by a single dose of lidocaine 2% (2 mg/kg). Then after 15 minutes, the patients from the RF group received ropivacaine 1% (1-3 mg/kg) and those from the BF group bupivacaine 0.5% (0.5-1 mg/kg). After 60 minutes 0.2% ropivacaine solution with fentanyl or 0.125% solution of bupivacaine with fentanyl was infused with the flow rate of 0.1 ml/kg/hr.

Depending on the allocation to the group, postoperative analgesia was continued either with 0.2% ropivacaine and fentanyl or 0.125% bupivacaine and fentanyl, based on the concentration and the flow rate described above. In addition, intravenous paracetamol was administered as standard every 6 hours (the maximum of 60 mg/kg daily) along with non steroidal anti-inflammatory drugs. In children > 14 years of age, ketoprofen was injected at the dose of 1 mg/kg (the maximum of 200 mg daily) and in younger children ibuprofen (orally or rectally, up to 30 mg/kg daily) every 8 hours. Metamizol was given as a "rescue drug" (20 mg/kg).

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Małopolska
      • Rabka-Zdrój, Małopolska, Poland, 34-700
        • Institute for Tuberculosis and Lung Diseases, Pediatric Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective thoracic surgery (thoracotomy or Ravitch procedure);
  • Analgesia: continuous thoracic epidural analgesia.

Exclusion Criteria:

  • American Society of Anesthesiologists physical status >III;
  • History of chronic pain or preoperative opioid use;
  • Oncological treatment;
  • Impaired verbal communication;
  • Removal of epidural catheter <24 h postoperatively;
  • Lack of postoperative chest drainage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine/Fentanyl
Drug: Ropivacaine/Fentanyl
Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Other Names:
  • ROPIVACAINE HYDROCHLORIDE 10 mg/ml
Active Comparator: Bupivacaine/Fentanyl
Drug: Bupivacaine/Fentanyl
Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Other Names:
  • BUPIVACAINE HYDROCHLORIDE 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Time Frame: postoperative day: 0-3
postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Time Frame: postoperative day: 0-3
postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Time Frame: postoperative day: 0-3
postoperative day: 0-3
Side Effect Occurrence
Time Frame: first 3 days after surgery
first 3 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of doses of metamizol as a "rescue drug"
Time Frame: postoperative day: 0-3
postoperative day: 0-3
Total fentanyl consumption [µg]
Time Frame: postoperative day: 0-3
postoperative day: 0-3
The number of nursing interventions undertaken to relive pain > 2/10 pts
Time Frame: postoperative day: 0-3
postoperative day: 0-3
Patient satisfaction
Time Frame: postoperative day 3
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good.
postoperative day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Investigators

  • Study Director: Lucyna Tomaszek, PhD, National Institute for Tuberculosis and Lung Diseases, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2015

Primary Completion (Actual)

March 14, 2017

Study Completion (Actual)

March 14, 2017

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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