Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT03393702
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2017-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2017-12-28', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)', 'timeFrame': 'postoperative day: 0-3'}, {'measure': 'Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)', 'timeFrame': 'postoperative day: 0-3'}, {'measure': 'Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)', 'timeFrame': 'postoperative day: 0-3'}], 'secondaryOutcomes': [{'measure': 'Total ropivacaine/fentanyl consumption.', 'timeFrame': 'postoperative day: 0-3'}, {'measure': 'Total morphine consumption.', 'timeFrame': 'postoperative day: 0-3'}, {'measure': 'Anxiety intensity scores.', 'timeFrame': 'before surgery, postoperative day 3', 'description': 'Patients rate their anxiety using State-Trait Anxiety Inventory.'}, {'measure': 'Side Effect Occurrence', 'timeFrame': 'first 3 days after surgery', 'description': 'Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, urinary retention, complication in relation to administering of the drugs to epidural space.'}, {'measure': 'The number of doses of metamizol as a "rescue drug"', 'timeFrame': 'postoperative day: 0-3'}, {'measure': 'Patient satisfaction.', 'timeFrame': 'first 3 days after surgery', 'description': 'Responses can range from 0 (very dissatisfied) to 10 (very satisfied).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Anxiety', 'Postoperative Complications', 'Patient Satisfaction'], 'conditions': ['Pain, Postoperative', 'Surgery, Thoracic']}, 'referencesModule': {'references': [{'pmid': '20418301', 'type': 'BACKGROUND', 'citation': 'Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.'}, {'pmid': '25230144', 'type': 'BACKGROUND', 'citation': 'Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.'}, {'pmid': '31596461', 'type': 'BACKGROUND', 'citation': 'Tomaszek L, Fenikowski D, Maciejewski P, Komotajtys H, Gawron D. Perioperative Gabapentin in Pediatric Thoracic Surgery Patients-Randomized, Placebo-Controlled, Phase 4 Trial. Pain Med. 2020 Aug 1;21(8):1562-1571. doi: 10.1093/pm/pnz207.'}, {'pmid': '36554581', 'type': 'DERIVED', 'citation': 'Fenikowski D, Tomaszek L. Factors Related to Anxiety in Paediatric Patients and Their Parents before and after a Modified Ravitch Procedure-A Single-Centre Cohort Study. Int J Environ Res Public Health. 2022 Dec 12;19(24):16701. doi: 10.3390/ijerph192416701.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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"\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5 - 18 years of age;\n* surgery: lateral thoracotomy or Ravitch procedure;\n* ASA 1-3;\n* postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine.\n\nExclusion Criteria:\n\n* allergy or sensitivity to gabapentin;\n* history of chronic pain or daily analgesic use;\n* diagnosed with psychiatric disorders;\n* treated oncologically;\n* with impaired verbal communication;\n* the lack of postoperative chest drainage.'}, 'identificationModule': {'nctId': 'NCT03393702', 'briefTitle': 'Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin', 'organization': {'class': 'OTHER', 'fullName': 'National Institute for Tuberculosis and Lung Diseases, Poland'}, 'officialTitle': 'Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study', 'orgStudyIdInfo': {'id': '10.11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin', 'description': '1. Single dose preoperative gabapentin.\n2. After surgery gabapentin 2 times per day for 3 days.', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': '1. Single dose preoperative placebo control.\n2. After surgery placebo 2 times per day for 3 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Gabapentin TEVA, capsules'], 'description': '1. Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin.\n2. Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day.', 'armGroupLabels': ['Gabapentin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1. Patients in this arm of the study receive identical placebo capsules 1 hour before surgery.\n2. Patients after surgery receive identical placebo capsules 2 times per day.', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34-700', 'city': 'Rabka-Zdrój', 'state': 'Małopolska', 'country': 'Poland', 'facility': 'Institute for Tuberculosis and Lung Diseases, Pediatric Division', 'geoPoint': {'lat': 49.60889, 'lon': 19.96654}}], 'overallOfficials': [{'name': 'Lucyna Tomaszek, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute for Tuberculosis and Lung Diseases, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute for Tuberculosis and Lung Diseases, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Nursing, Specialist Nurse in Anesthesia and Intensive Care', 'investigatorFullName': 'Lucyna Tomaszek, PhD, RN', 'investigatorAffiliation': 'National Institute for Tuberculosis and Lung Diseases, Poland'}}}}