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Completed

NCT Number: NCT03393702

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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, 34-700, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug
  • 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.

Other names: Gabapentin TEVA, capsules

Placebo

Drug
  • 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.

Primary outcomes

  1. Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)

    Time frame: postoperative day: 0-3

  2. Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)

    Time frame: postoperative day: 0-3

  3. Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)

    Time frame: postoperative day: 0-3

Secondary outcomes

  1. Total ropivacaine/fentanyl consumption.

    Time frame: postoperative day: 0-3

  2. Total morphine consumption.

    Time frame: postoperative day: 0-3

  3. Anxiety intensity scores.

    Time frame: before surgery, postoperative day 3

    Patients rate their anxiety using State-Trait Anxiety Inventory.

  4. 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.

  5. The number of doses of metamizol as a "rescue drug"

    Time frame: postoperative day: 0-3

  6. Patient satisfaction.

    Time frame: first 3 days after surgery

    Responses can range from 0 (very dissatisfied) to 10 (very satisfied).

Sponsors and collaborators

Lead sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 8, 2018
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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