Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:30 AM
Study NCT ID:
NCT00853333
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2009-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sedation and Pain (The Effect of IV Sedation on Pain Perception)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'froelich@uab.edu', 'phone': '(205)975-0145', 'title': 'Michael Froelich', 'organization': 'University of Alabama at Birmigham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dexmedetomidine', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Midazolam', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Propofol', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Rating Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine'}, {'id': 'OG001', 'title': 'Midazolam'}, {'id': 'OG002', 'title': 'Propofol'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.253', 'spread': '0.168', 'groupId': 'OG000'}, {'value': '0.762', 'spread': '0.171', 'groupId': 'OG001'}, {'value': '-0.346', 'spread': '0.159', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Sedation', 'description': 'Mechanical Slide Algometer (www.decisionaidsonline.com), Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale.\n\nChange Time Points: Baseline (no sedation), Sedation. Same Day Intervention.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexmedetomidine', 'description': 'Sedation Arm 1, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.'}, {'id': 'FG001', 'title': 'Midazolam', 'description': 'Sedation Arm 2, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.'}, {'id': 'FG002', 'title': 'Propofol', 'description': 'Sedation Arm 3, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine'}, {'id': 'BG001', 'title': 'Midazolam'}, {'id': 'BG002', 'title': 'Propofol'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.74', 'spread': '4.47', 'groupId': 'BG000'}, {'value': '24.46', 'spread': '4.64', 'groupId': 'BG001'}, {'value': '25.83', 'spread': '5.41', 'groupId': 'BG002'}, {'value': '25.01', 'spread': '4.84', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2009-02-26', 'resultsFirstSubmitDate': '2013-08-23', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-24', 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Rating Change', 'timeFrame': 'Sedation', 'description': 'Mechanical Slide Algometer (www.decisionaidsonline.com), Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale.\n\nChange Time Points: Baseline (no sedation), Sedation. Same Day Intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain', 'Propofol', 'Dexmedetomidine', 'Midazolam', 'Effects of sedation on pain perception.'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '23314164', 'type': 'RESULT', 'citation': 'Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.'}]}, 'descriptionModule': {'briefSummary': "The investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fMRI(objective).", 'detailedDescription': "We propose to contrast and compare the effect of propofol and midazolam, two GABA-related sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in human volunteers by asking a participant to rate their pain and by evaluating a subject's brain activation using fMRI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy subjects\n\n* 19 years or older able to follow study instructions\n\nExclusion Criteria:\n\n* Age less than 19 or greater than 40\n* Pregnant female\n* Obesity (BMI \\> or =35)\n* Non-English speaking/reading participants\n* Sleep apnea\n* Pulmonary problems such as moderate or severe bronchial asthma\n* Cardiovascular problems such as hypertension\n* History of claustrophobia\n* Presence of a pacemaker, defibrillator, surgically placed metallic object (e.g., hip replacement)or other implanted device\n* Presence of an unremoved bullet or shrapnel in the body\n* Presence of a prosthetic that is not removable\n* Presence of a hearing aid needed for hearing\n* Head girth exceeding that of the head coil used in the magnet\n* Extensive metalwork on or in teeth, or irremovable false teeth or bridgework\n* Epilepsy\n* Chronic analgesic medication\n* Excessive tattoos (due to local skin heating with tattoos containing ferromagnetic particles)\n* History of surgery for which details are unavailable\n* Allery due to study drugs\n* History of drug abuse'}, 'identificationModule': {'nctId': 'NCT00853333', 'briefTitle': 'Sedation and Pain (The Effect of IV Sedation on Pain Perception)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Sedation and Pain (The Effect of IV Sedation on Pain Perception)', 'orgStudyIdInfo': {'id': 'F081016014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Administration via an IV', 'interventionNames': ['Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'Administration via an IV', 'interventionNames': ['Drug: midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Administration via an IV', 'interventionNames': ['Drug: dexmedetomidine']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'midazolam', 'type': 'DRUG', 'armGroupLabels': ['Midazolam']}, {'name': 'propofol', 'type': 'DRUG', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Michael A Froelich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society of Regional Anesthesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Michael Froelich', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}