Institute for Tuberculosis and Lung Diseases, Pediatric Division
Rabka-Zdrój, Małopolska, 34-700, Poland
NCT Number: NCT03444636
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.
Looking for future studies?
Notify Me5 year–18 year
All sexes
Interventional
Phase 4
Rabka-Zdrój, Małopolska, 34-700, Poland
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Other names: ROPIVACAINE HYDROCHLORIDE 10 mg/ml
Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Other names: BUPIVACAINE HYDROCHLORIDE 0.5%
Time frame: postoperative day: 0-3
Time frame: postoperative day: 0-3
Time frame: postoperative day: 0-3
Time frame: first 3 days after surgery
Time frame: postoperative day: 0-3
Time frame: postoperative day: 0-3
Time frame: postoperative day: 0-3
Time frame: postoperative day 3
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good.
National Institute for Tuberculosis and Lung Diseases, Poland
Other
The Efficacy and Safety of Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy - a Prospective Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03393702
Anxiety Disorders, Behavior
Rabka-Zdrój, Małopolska, Poland
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT07334548
Complication,Postoperative, Hernia
Karachi, Sindh, Pakistan
View Trial DetailsNCT06978491
Neurologic Manifestations, Pain
Eskişehir, Eski̇şehi̇r, Turkey (Türkiye)
View Trial Details