Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
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|ClinicalTrials.gov Identifier: NCT03393702|
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Surgery, Thoracic||Drug: Gabapentin Drug: Placebo||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study|
|Actual Study Start Date :||May 9, 2017|
|Actual Primary Completion Date :||December 30, 2019|
|Actual Study Completion Date :||December 3, 2020|
Other Name: Gabapentin TEVA, capsules
Placebo Comparator: Placebo Control
- 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. [ Time Frame: before surgery, postoperative day 3 ]Patients rate their anxiety using State-Trait Anxiety Inventory.
- Side Effect Occurrence [ 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.
- The number of doses of metamizol as a "rescue drug" [ Time Frame: postoperative day: 0-3 ]
- Patient satisfaction. [ Time Frame: first 3 days after surgery ]Responses can range from 0 (very dissatisfied) to 10 (very satisfied).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393702
|Institute for Tuberculosis and Lung Diseases, Pediatric Division|
|Rabka-Zdrój, Małopolska, Poland, 34-700|
|Study Director:||Lucyna Tomaszek, PhD||National Institute for Tuberculosis and Lung Diseases, Poland|