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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444636
• Other study ID #: 10.7
• Status: Completed
• Phase: Phase 4
• Start date: March 2, 2015
• Est. completion date: March 14, 2017

Study information

• Verified date: May 2020
• Source: National Institute for Tuberculosis and Lung Diseases, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 14, 2017
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery, Thoracic

Intervention

Drug:
• Ropivacaine/Fentanyl
Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
• Bupivacaine/Fentanyl
Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr

Locations

Country	Name	City	State
Poland	Institute for Tuberculosis and Lung Diseases, Pediatric Division	Rabka-Zdrój	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Tuberculosis and Lung Diseases, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. — View Citation

Ecoffey C, Lacroix F, Giaufré E, Orliaguet G, Courrèges P; Association des Anesthésistes Réanimateurs Pédiatriques d'Expression Française (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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)		postoperative day: 0-3
Primary	Pain intensity scores during deep breathing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)		postoperative day: 0-3
Primary	Pain intensity scores during coughing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)		postoperative day: 0-3
Primary	Side Effect Occurrence		first 3 days after surgery
Secondary	Total fentanyl consumption [µg]		postoperative day: 0-3
Secondary	The number of doses of metamizol as a "rescue drug"		postoperative day: 0-3
Secondary	The number of nursing interventions undertaken to relive pain > 2/10 pts		postoperative day: 0-3
Secondary	Patient satisfaction	Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good.	postoperative day 3