drugset / Trial / NCT03444636
Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-03-02
- Primary completion
- 2017-03-14
- Completion
- 2017-03-14
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.125 % | Other |
| Subject | Ropivacaine | Other / unclassified | 0.2 % | Other |
| Comparator | Fentanyl | Other / unclassified | 5 ug/ml | Other |
Indications
No indication recorded.