Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy
Primary Purpose
Pain, Postoperative, Surgery, Thoracic
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Ropivacaine/Fentanyl
Bupivacaine/Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Multimodal analgesia, Thoracic epidural, Postoperative pain, Postoperative Complications, Patient Satisfaction
Eligibility Criteria
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.
Sites / Locations
- Institute for Tuberculosis and Lung Diseases, Pediatric Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ropivacaine/Fentanyl
Bupivacaine/Fentanyl
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Pain intensity scores during coughing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Side Effect Occurrence
Secondary Outcome Measures
Total fentanyl consumption [µg]
The number of doses of metamizol as a "rescue drug"
The number of nursing interventions undertaken to relive pain > 2/10 pts
Patient satisfaction
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good.
Full Information
NCT ID
NCT03444636
First Posted
February 16, 2018
Last Updated
May 26, 2020
Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
1. Study Identification
Unique Protocol Identification Number
NCT03444636
Brief Title
Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy
Official Title
The Efficacy and Safety of Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy - a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2015 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Surgery, Thoracic
Keywords
Multimodal analgesia, Thoracic epidural, Postoperative pain, Postoperative Complications, Patient Satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine/Fentanyl
Arm Type
Experimental
Arm Title
Bupivacaine/Fentanyl
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine/Fentanyl
Other Intervention Name(s)
ROPIVACAINE HYDROCHLORIDE 10 mg/ml
Intervention Description
Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Intervention Type
Drug
Intervention Name(s)
Bupivacaine/Fentanyl
Other Intervention Name(s)
BUPIVACAINE HYDROCHLORIDE 0.5%
Intervention Description
Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Side Effect Occurrence
Time Frame
first 3 days after surgery
Secondary Outcome Measure Information:
Title
Total fentanyl consumption [µg]
Time Frame
postoperative day: 0-3
Title
The number of doses of metamizol as a "rescue drug"
Time Frame
postoperative day: 0-3
Title
The number of nursing interventions undertaken to relive pain > 2/10 pts
Time Frame
postoperative day: 0-3
Title
Patient satisfaction
Description
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good.
Time Frame
postoperative day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucyna Tomaszek, PhD
Organizational Affiliation
National Institute for Tuberculosis and Lung Diseases, Poland
Official's Role
Study Director
Facility Information:
Facility Name
Institute for Tuberculosis and Lung Diseases, Pediatric Division
City
Rabka-Zdrój
State/Province
Małopolska
ZIP/Postal Code
34-700
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25293474
Citation
Misiolek H, Cettler M, Woron J, Wordliczek J, Dobrogowski J, Mayzner-Zawadzka E. The 2014 guidelines for post-operative pain management. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):221-44. doi: 10.5603/AIT.2014.0041. No abstract available.
Results Reference
background
PubMed Identifier
26827847
Citation
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
Results Reference
background
PubMed Identifier
25599577
Citation
Schnabel A, Thyssen NM, Goeters C, Zheng H, Zahn PK, Van Aken H, Pogatzki-Zahn EM. Age- and procedure-specific differences of epidural analgesia in children--a database analysis. Pain Med. 2015 Mar;16(3):544-53. doi: 10.1111/pme.12633. Epub 2015 Jan 19.
Results Reference
background
PubMed Identifier
21199114
Citation
Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.
Results Reference
background
PubMed Identifier
11359592
Citation
Lejus C, Surbled M, Schwoerer D, Renaudin M, Guillaud C, Berard L, Pinaud M. Postoperative epidural analgesia with bupivacaine and fentanyl: hourly pain assessment in 348 paediatric cases. Paediatr Anaesth. 2001 May;11(3):327-32. doi: 10.1046/j.1460-9592.2001.00659.x.
Results Reference
background
PubMed Identifier
31103498
Citation
Tomaszek L, Fenikowski D, Komotajtys H, Gawron D. Ropivacaine/Fentanyl vs. Bupivacaine/Fentanyl for Pain Control in Children after Thoracic Surgery: A Randomized Study. Pain Manag Nurs. 2019 Aug;20(4):390-397. doi: 10.1016/j.pmn.2019.02.007. Epub 2019 May 15.
Results Reference
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PubMed Identifier
30451243
Citation
Tomaszek L, Fenikowski D, Gawron D, Komotajtys H. Comparative efficacy of continuous infusion of bupivacaine/fentanyl and ropivacaine/fentanyl for paediatric pain control after the Ravitch procedure and thoracotomy. A prospective randomized study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Dec;163(4):366-373. doi: 10.5507/bp.2018.072. Epub 2018 Nov 16.
Results Reference
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Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy
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