MedTrace Logo

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

NCT03393702 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-09-08

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Surgery, Thoracic

Interventions

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.

Sponsors & Collaborators

  • National Institute for Tuberculosis and Lung Diseases, Poland

    lead OTHER

Principal Investigators

  • Lucyna Tomaszek, PhD · National Institute for Tuberculosis and Lung Diseases, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2019-12-30
Completion
2020-12-03

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03393702 on ClinicalTrials.gov