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

August 31, 2021 updated by: Lucyna Tomaszek, PhD, RN, National Institute for Tuberculosis and Lung Diseases, Poland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Małopolska
      • Rabka-Zdrój, Małopolska, Poland, 34-700
        • Institute for Tuberculosis and Lung Diseases, Pediatric Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gabapentin
  1. Single dose preoperative gabapentin.
  2. After surgery gabapentin 2 times per day for 3 days.
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.
Other Names:
  • Gabapentin TEVA, capsules
Placebo Comparator: Placebo Control
  1. Single dose preoperative placebo control.
  2. After surgery placebo 2 times per day for 3 days.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Investigators

  • Study Director: Lucyna Tomaszek, PhD, National Institute for Tuberculosis and Lung Diseases, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2017

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 3, 2020

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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