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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393702
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Lucyna Tomaszek, PhD, RN, National Institute for Tuberculosis and Lung Diseases, Poland

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 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Surgery, Thoracic Drug: Gabapentin Drug: Placebo Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393702


Locations
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Poland
Institute for Tuberculosis and Lung Diseases, Pediatric Division
Rabka-Zdrój, Małopolska, Poland, 34-700
Sponsors and Collaborators
National Institute for Tuberculosis and Lung Diseases, Poland
Investigators
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Study Director: Lucyna Tomaszek, PhD National Institute for Tuberculosis and Lung Diseases, Poland
Publications:
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Responsible Party: Lucyna Tomaszek, PhD, RN, Head of Nursing, Specialist Nurse in Anesthesia and Intensive Care, National Institute for Tuberculosis and Lung Diseases, Poland
ClinicalTrials.gov Identifier: NCT03393702    
Other Study ID Numbers: 10.11
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lucyna Tomaszek, PhD, RN, National Institute for Tuberculosis and Lung Diseases, Poland:
Postoperative pain
Anxiety
Postoperative Complications
Patient Satisfaction
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents