Status:
COMPLETED
Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy
Lead Sponsor:
National Institute for Tuberculosis and Lung Diseases, Poland
Conditions:
Pain, Postoperative
Surgery, Thoracic
Eligibility:
All Genders
5-18 years
Phase:
PHASE4
Brief 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 mu...
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, pa...
Eligibility Criteria
Inclusion
- Elective thoracic surgery (thoracotomy or Ravitch procedure);
- Analgesia: continuous thoracic epidural analgesia.
Exclusion
- 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.
Key Trial Info
Start Date :
March 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2017
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03444636
Start Date
March 2 2015
End Date
March 14 2017
Last Update
May 28 2020
Active Locations (1)
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1
Institute for Tuberculosis and Lung Diseases, Pediatric Division
Rabka-Zdrój, Małopolska, Poland, 34-700