The study is performed in patients aged 5-18 years after thoracic surgery. The primary aim of this trial is to determine whether the use of gabapentin as a component of multimodal analgesic regiments reduces pain scores following thoracic surgery in pediatric patients. The secondary objective of the trial are to evaluate whether the use of gabapentin reduces postoperative anxiety scores and consumption of ropivacaine with fentanyl, decreases side-effects, and improves patient satisfaction.
The subjects are randomized to the Gabapentin or Placebo group. All patients receive preoperative gabapentin (15 mg/kg, treatment) or placebo, respectively and after surgery either gabapentin (7,5 mg/kg, treatment) or placebo 2 times per day for 3 days, respectively. Patients are subjected to the same anaesthesia protocol. Postoperative analgesia are achieved with either continuous ropivacaine 0.2%/fentanyl 5.0 μg/ml infusion through a thoracic epidural catheter (N=40; Gabapentin n=20, Placebo n=20), or intravenous infusion of morphine (N=40; Gabapentin n=20, Placebo n=20). All patients receive acetaminophen and non-steroidal anti-inflammatory drugs, and metamizol as a "rescue drug" The intravenous infusion of morphine grup was expanded on the basis of the bioethics commission's decision KB-125/2019 (N=64; Gabapentin n=32, Placebo n=32).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
1. Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin. 2. Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day.
1. Patients in this arm of the study receive identical placebo capsules 1 hour before surgery. 2. Patients after surgery receive identical placebo capsules 2 times per day.
Institute for Tuberculosis and Lung Diseases, Pediatric Division
Rabka-Zdrój, Małopolska, Poland
Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
Total ropivacaine/fentanyl consumption.
Time frame: postoperative day: 0-3
Total morphine consumption.
Time frame: postoperative day: 0-3
Anxiety intensity scores.
Patients rate their anxiety using State-Trait Anxiety Inventory.
Time frame: before surgery, postoperative day 3
Side Effect Occurrence
Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, urinary retention, complication in relation to administering of the drugs to epidural space.
Time frame: first 3 days after surgery
The number of doses of metamizol as a "rescue drug"
Time frame: postoperative day: 0-3
Patient satisfaction.
Responses can range from 0 (very dissatisfied) to 10 (very satisfied).
Time frame: first 3 days after surgery
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