Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study

Conditions
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Pain, Postoperative, Surgery, Thoracic

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5 - 18 years of age; surgery: lateral thoracotomy or Ravitch procedure; ASA 1-3; postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine. Exclusion Criteria: allergy or sensitivity to gabapentin; history of chronic pain or daily analgesic use; diagnosed with psychiatric disorders; treated oncologically; with impaired verbal communication; the lack of postoperative chest drainage.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Single dose preoperative gabapentin. After surgery gabapentin 2 times per day for 3 days. | Drug: Gabapentin<br>* Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin. Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day.<br>* Other names: Gabapentin TEVA, capsules;|
| Placebo Comparator: Placebo Control<br>Single dose preoperative placebo control. After surgery placebo 2 times per day for 3 days. | Drug: Placebo<br>* Patients in this arm of the study receive identical placebo capsules 1 hour before surgery. Patients after surgery receive identical placebo capsules 2 times per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.) |  | postoperative day: 0-3 | 
| Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.) |  | postoperative day: 0-3 | 
| Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.) |  | postoperative day: 0-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total ropivacaine/fentanyl consumption. |  | postoperative day: 0-3 | 
| Total morphine consumption. |  | postoperative day: 0-3 | 
| Anxiety intensity scores. | Patients rate their anxiety using State-Trait Anxiety Inventory. | 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. | first 3 days after surgery | 
| The number of doses of metamizol as a rescue drug |  | postoperative day: 0-3 | 
| Patient satisfaction. | Responses can range from 0 (very dissatisfied) to 10 (very satisfied). | first 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Anxiety, Postoperative Complications, Patient Satisfaction