Institute for Tuberculosis and Lung Diseases, Pediatric Division
Rabka-Zdrój, Małopolska, 34-700, Poland
NCT Number: NCT03393702
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.
Looking for future studies?
Notify Me5 year–18 year
All sexes
Interventional
Phase 4
Rabka-Zdrój, Małopolska, 34-700, Poland
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Gabapentin TEVA, capsules
Time frame: postoperative day: 0-3
Time frame: postoperative day: 0-3
Time frame: postoperative day: 0-3
Time frame: postoperative day: 0-3
Time frame: postoperative day: 0-3
Time frame: before surgery, postoperative day 3
Patients rate their anxiety using State-Trait Anxiety Inventory.
Time frame: first 3 days after surgery
Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, urinary retention, complication in relation to administering of the drugs to epidural space.
Time frame: postoperative day: 0-3
Time frame: first 3 days after surgery
Responses can range from 0 (very dissatisfied) to 10 (very satisfied).
National Institute for Tuberculosis and Lung Diseases, Poland
Other
Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind 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.
NCT03444636
Behavior, Health Behavior
Rabka-Zdrój, Małopolska, Poland
View Trial DetailsNCT03488459
Anxiety Disorders, Mental Disorders
Rabka-Zdrój, Małopolska, Poland
View Trial DetailsNCT03685422
Agnosia, Anxiety
Singapore
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial Details