NCT03393702

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Pain, Postoperative
• Surgery, Thoracic

Interventions

Type	Name	Description
DRUG	Gabapentin	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.
DRUG	Placebo	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.

Timeline

• Start date: 2017-05-09
• Primary completion: 2019-12-30
• Completion: 2020-12-03
• First posted: 2018-01-08
• Last updated: 2021-09-08

Locations

1 site across 1 country: Poland