Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT02668094
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2016-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pregabalin on Pain of Propofol Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2016-01-22', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propofol injection pain', 'timeFrame': '10 seconds after injection of propofol', 'description': 'Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['propofol', 'lidocaine', 'pregabalin'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Pain is a common side effect of propofol injection. The purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain.', 'detailedDescription': 'In a randomized, double blind, prospective trial, 120 patients were allocated to one of three groups (each n=40) receiving intravenous lidocaine 40mg (group L), oral pregabalin 75 mg (group LP), and oral pregabalin 150 mg (group HP) as pretreatment, followed by injection of 25% of 2 mg/kg propofol. Pain was assessed by a four point scale (0=no, 1=mild, 2=moderate, 3=severe pain).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient underwent elective dental surgery.\n\nExclusion Criteria:\n\n* Patient with a history of adverse response to lidocaine or pregabalin,\n* Patient with cardiovascular or respiratory disease,\n* Patient who takes any sedatives, analgesics, or anticonvulsants within 24 hours before surgery.'}, 'identificationModule': {'nctId': 'NCT02668094', 'briefTitle': 'The Effect of Pregabalin on Pain of Propofol Injection', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': 'The Effect of Pregabalin on Pain of Propofol Injection', 'orgStudyIdInfo': {'id': '2015-03-037-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group L', 'description': 'Lidocaine 40mg was given intravenously before injection of propofol', 'interventionNames': ['Drug: Lidocaine', 'Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group LP', 'description': 'Pregabalin 75 mg was given orally 2 hour before surgery', 'interventionNames': ['Drug: Pregabalin', 'Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group HP', 'description': 'Pregabalin 150 mg was given orally 2 hour before surgery', 'interventionNames': ['Drug: Pregabalin', 'Drug: propofol']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Group L']}, {'name': 'Pregabalin', 'type': 'DRUG', 'armGroupLabels': ['Group HP', 'Group LP']}, {'name': 'propofol', 'type': 'DRUG', 'armGroupLabels': ['Group HP', 'Group L', 'Group LP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Younghoon Jeon, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National Hosptial'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Younghoon Jeon', 'investigatorAffiliation': 'Kyungpook National University Hospital'}}}}