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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03444636
Enrollment
94
Registered
2018-02-23
Start date
2015-03-02
Completion date
2017-03-14
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Surgery, Thoracic

Keywords

Multimodal analgesia, Thoracic epidural, Postoperative pain, Postoperative Complications, Patient Satisfaction

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).

Interventions

DRUGRopivacaine/Fentanyl

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

DRUGBupivacaine/Fentanyl

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

Sponsors

National Institute for Tuberculosis and Lung Diseases, Poland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Side Effect Occurrencefirst 3 days after surgery
Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)postoperative day: 0-3

Secondary

MeasureTime frameDescription
Total fentanyl consumption [µg]postoperative day: 0-3
The number of doses of metamizol as a rescue drugpostoperative day: 0-3
The number of nursing interventions undertaken to relive pain > 2/10 ptspostoperative day: 0-3
Patient satisfactionpostoperative day 3Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026