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Completed

NCT Number: NCT03444636

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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, 34-700, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine/Fentanyl

Drug

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

Other names: ROPIVACAINE HYDROCHLORIDE 10 mg/ml

Bupivacaine/Fentanyl

Drug

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

Other names: BUPIVACAINE HYDROCHLORIDE 0.5%

Primary outcomes

  1. 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

  2. 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

  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

  4. Side Effect Occurrence

    Time frame: first 3 days after surgery

Secondary outcomes

  1. Total fentanyl consumption [µg]

    Time frame: postoperative day: 0-3

  2. The number of doses of metamizol as a "rescue drug"

    Time frame: postoperative day: 0-3

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

    Time frame: postoperative day: 0-3

  4. 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.

Sponsors and collaborators

Lead sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2018
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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