Status:

COMPLETED

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

Lead Sponsor:

National Institute for Tuberculosis and Lung Diseases, Poland

Conditions:

Pain, Postoperative

Surgery, Thoracic

Eligibility:

All Genders

5-18 years

Phase:

PHASE4

Brief 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 ...

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/...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 9 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 3 2020

Estimated Enrollment :

104 Patients enrolled

Trial Details

Trial ID

NCT03393702

Start Date

May 9 2017

End Date

December 3 2020

Last Update

September 8 2021

Active Locations (1)

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1

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, Poland, 34-700