Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-07 @ 11:11 AM
Study NCT ID:
NCT01967433
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2013-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004155', 'term': 'Diphenhydramine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'salman-nusrat@ouhsc.edu', 'phone': '4052715428', 'title': 'Salman Nusrat', 'organization': 'University of Oklahoma Health Sciences Center and VAMC, Oklahoma City'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Preprocedure, procedural, post procedure and 24 hr follow up', 'description': 'Hypoxia (defined as O 2 saturation less than 89% lasting for more than 30 seconds), hypertension (20 mm Hg increase in blood pressure from baseline, provided this is \\>140 mm Hg systolic and 90 mm Hg diastolic), hypotension (20 mmHg decrease in blood pressure from baseline, provided this is \\<100 mm Hg systolic or 60 mm Hg diastolic), bradycardia (a decrease in heart rate of \\>20 bpm, provided this is less than 60), tachycardia (an increase in heart rate of \\>20 bpm, provided this \\>100 bpm)', 'eventGroups': [{'id': 'EG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 17, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 25, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reversal Agent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachypnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dosage of Fentanyl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives\n\nDiphenhydramine'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '125.4', 'spread': '56.2', 'groupId': 'OG000'}, {'value': '126.9', 'spread': '53.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From induction (first dose of sedative) to end of procedure', 'description': 'Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.', 'unitOfMeasure': '(μg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives\n\nDiphenhydramine Allocated: 61 Lost to follow up: 0 Analyzed: 61'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives\n\nPlacebo Allocated: 59 Lost to follow up: 0 Analyzed: 58'}], 'classes': [{'title': 'Physician rating', 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Nurse rating', 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the colonoscopy and 24 hours after discharge', 'description': 'Quality of sedation will be accessed by the nurse and the physician at the end of procedure.\n\nName: 10 point visual analogue scale Minimum score: 1 (worse) Maximum score: 10 (better)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives\n\nDiphenhydramine'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives\n\nPlacebo'}], 'classes': [{'title': 'Procedure time', 'categories': [{'measurements': [{'value': '34.8', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '34.7', 'spread': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Recovery', 'categories': [{'measurements': [{'value': '34.4', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Induction', 'categories': [{'measurements': [{'value': '6.4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time from induction (first dose of sedative) to discharge', 'description': 'Induction period (time from first dose of fentanyl to scope insertion), procedural time (time from scope insertion to scope out), and recovery time (time from scope out to discharge) were recorded by the nursing staff in their standard documentation.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives\n\nDiphenhydramine'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives\n\nPlacebo'}], 'classes': [{'title': 'Hypotension', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Desaturation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Apnea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Arrhythmia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reversal agent use', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tachypnea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From induction (first dose of sedative) to discharge', 'description': 'Following adverse events will be recorded: (1)Hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, (2)hypotension defined as systolic BP less than 90 mmhg and (3)use of reversal agents i.e Naloxone or Flumazenil', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24 Hour Follow up Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives\n\nDiphenhydramine'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '3.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'About 24 hours after the procedure', 'description': 'At 24 hr follow up patients were asked to rate the level of pain during the procedure using 10 point scale.\n\n10 point visual analogue scale minimum= 0 (better) maximum =10 (worse)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dosage of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From induction (first dose of sedative) to end of procedure', 'description': 'Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24 Hour Follow up Amnesia Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives\n\nPlacebo'}, {'id': 'OG001', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives\n\nDiphenhydramine'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At about 24 after the procedure', 'description': 'Patient were also asked to rate amnesia on a 10 point scale 24 after discharge. minimum= 0 (worse) maximum =10 (better)', 'unitOfMeasure': 'score on a 10 point point scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives\n\nDiphenhydramine Allocated: 61 Lost to follow up: 0 Analyzed: 61'}, {'id': 'FG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives\n\nPlacebo Allocated: 59 Lost to follow up: 0 Analyzed: 58'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives'}, {'id': 'BG001', 'title': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '60.1', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '60.37', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Others', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-15', 'size': 380276, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-19T10:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2013-10-11', 'resultsFirstSubmitDate': '2018-08-24', 'studyFirstSubmitQcDate': '2013-10-17', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-03', 'studyFirstPostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of Fentanyl', 'timeFrame': 'From induction (first dose of sedative) to end of procedure', 'description': 'Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.'}], 'secondaryOutcomes': [{'measure': 'Quality of Sedation', 'timeFrame': 'During the colonoscopy and 24 hours after discharge', 'description': 'Quality of sedation will be accessed by the nurse and the physician at the end of procedure.\n\nName: 10 point visual analogue scale Minimum score: 1 (worse) Maximum score: 10 (better)'}, {'measure': 'Duration of Procedure', 'timeFrame': 'Time from induction (first dose of sedative) to discharge', 'description': 'Induction period (time from first dose of fentanyl to scope insertion), procedural time (time from scope insertion to scope out), and recovery time (time from scope out to discharge) were recorded by the nursing staff in their standard documentation.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From induction (first dose of sedative) to discharge', 'description': 'Following adverse events will be recorded: (1)Hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, (2)hypotension defined as systolic BP less than 90 mmhg and (3)use of reversal agents i.e Naloxone or Flumazenil'}, {'measure': '24 Hour Follow up Pain Score', 'timeFrame': 'About 24 hours after the procedure', 'description': 'At 24 hr follow up patients were asked to rate the level of pain during the procedure using 10 point scale.\n\n10 point visual analogue scale minimum= 0 (better) maximum =10 (worse)'}, {'measure': 'Dosage of Midazolam', 'timeFrame': 'From induction (first dose of sedative) to end of procedure', 'description': 'Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.'}, {'measure': '24 Hour Follow up Amnesia Score', 'timeFrame': 'At about 24 after the procedure', 'description': 'Patient were also asked to rate amnesia on a 10 point scale 24 after discharge. minimum= 0 (worse) maximum =10 (better)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fentanyl', 'Midazolam', 'Sedation', 'Patient tolerance', 'Duration of colonoscopy'], 'conditions': ['Colonoscopy', 'Adjunct Anesthesia Medication']}, 'referencesModule': {'references': [{'pmid': '15330904', 'type': 'BACKGROUND', 'citation': 'Abraham NS, Fallone CA, Mayrand S, Huang J, Wieczorek P, Barkun AN. Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy: a Canadian randomized controlled cost-outcome study. Am J Gastroenterol. 2004 Sep;99(9):1692-9. doi: 10.1111/j.1572-0241.2004.40157.x.'}, {'pmid': '12492190', 'type': 'BACKGROUND', 'citation': 'Zubarik R, Ganguly E, Benway D, Ferrentino N, Moses P, Vecchio J. Procedure-related abdominal discomfort in patients undergoing colorectal cancer screening: a comparison of colonoscopy and flexible sigmoidoscopy. Am J Gastroenterol. 2002 Dec;97(12):3056-61. doi: 10.1111/j.1572-0241.2002.07101.x.'}, {'pmid': '7889437', 'type': 'BACKGROUND', 'citation': 'Bergeron P, Enns J, Delima L, Dupuis JY, Wynands JE. Effects of routine premedication for cardiac catheterization on sedation, level of anxiety and arterial oxygen saturation. Can J Cardiol. 1995 Mar;11(3):201-5.'}, {'pmid': '6432093', 'type': 'BACKGROUND', 'citation': 'Cook PJ, Flanagan R, James IM. Diazepam tolerance: effect of age, regular sedation, and alcohol. Br Med J (Clin Res Ed). 1984 Aug 11;289(6441):351-3. doi: 10.1136/bmj.289.6441.351.'}, {'pmid': '16187188', 'type': 'BACKGROUND', 'citation': 'Pena LR, Mardini HE, Nickl NJ. Development of an instrument to assess and predict satisfaction and poor tolerance among patients undergoing endoscopic procedures. Dig Dis Sci. 2005 Oct;50(10):1860-71. doi: 10.1007/s10620-005-2952-7.'}, {'pmid': '2351253', 'type': 'BACKGROUND', 'citation': "Keeffe EB, O'Connor KW. 1989 A/S/G/E survey of endoscopic sedation and monitoring practices. Gastrointest Endosc. 1990 May-Jun;36(3 Suppl):S13-8."}, {'pmid': '17009113', 'type': 'BACKGROUND', 'citation': 'Hirsh I, Vaissler A, Chernin J, Segol O, Pizov R. Fentanyl or tramadol, with midazolam, for outpatient colonoscopy: analgesia, sedation, and safety. Dig Dis Sci. 2006 Nov;51(11):1946-51. doi: 10.1007/s10620-006-9413-9. Epub 2006 Sep 29.'}, {'pmid': '16377322', 'type': 'BACKGROUND', 'citation': 'Tu RH, Grewall P, Leung JW, Suryaprasad AG, Sheykhzadeh PI, Doan C, Garcia JC, Zhang N, Prindiville T, Mann S, Trudeau W. Diphenhydramine as an adjunct to sedation for colonoscopy: a double-blind randomized, placebo-controlled study. Gastrointest Endosc. 2006 Jan;63(1):87-94. doi: 10.1016/j.gie.2005.08.015.'}, {'pmid': '20047024', 'type': 'BACKGROUND', 'citation': 'Roach CL, Husain N, Zabinsky J, Welch E, Garg R. Moderate sedation for echocardiography of preschoolers. Pediatr Cardiol. 2010 May;31(4):469-73. doi: 10.1007/s00246-009-9622-z. Epub 2010 Jan 3.'}, {'pmid': '15825733', 'type': 'BACKGROUND', 'citation': 'Hofmeister EH, Egger CM. Evaluation of diphenhydramine as a sedative for dogs. J Am Vet Med Assoc. 2005 Apr 1;226(7):1092-4. doi: 10.2460/javma.2005.226.1092.'}, {'pmid': '20865683', 'type': 'BACKGROUND', 'citation': 'Husain Z, Hussain K, Nair R, Steinman R. Diphenhydramine induced QT prolongation and torsade de pointes: An uncommon effect of a common drug. Cardiol J. 2010;17(5):509-11.'}]}, 'descriptionModule': {'briefSummary': 'To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce the amount of standard sedatives used during colonoscopy in patients on chronic opioids.', 'detailedDescription': "Specific Aims:\n\nThe primary aim of our study is to determine if addition of Diphenhydramine to Fentanyl and Midazolam will decrease the dose of Fentanyl and Midazolam used during colonoscopy in individuals on chronic opioids. Secondarily we will be looking at quality of sedation, duration of colonoscopy, time to reach cecum and adverse effects (hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, hypotension defined as systolic BP less than 90 mmhg and use of reversal agents i.e Naloxone or Flumazenil).\n\nDay of Procedure:\n\nAfter consent is obtained the medical records of the patients will be reviewed and demographic information, co-morbidities, current medication will be extracted and recorded.\n\nOn the day of colonoscopy Alcohol use disorder inventory (AUDIT) will be used to screen for alcohol abuse. AUDIT was developed by World Health Organization and has been validated over a period of 2 decades. It consist of 10 questions, each question is scored 0-4 on the basis of subjects alcohol use. It takes about 2-4 minutes to complete. A score 10 or greater is highly specific or alcohol use.\n\nSubjects will be checked in and prepared according to routine protocols of the VA medical center. Participants will be randomly assigned to receive either 50 mg of diphenhydramine or 10 ml of 0.9% sodium chloride. On the day of colonoscopy randomization will be performed by an independent investigator who is a pharmacist at VA medical center using the website http://www.randomization.com. She will also prepare and dispense medication. Each endoscopy team will consist of an attending gastroenterologist, gastroenterology fellow and two nurses. Medications will be administered by one of the nurses under the direct supervision of the physician.\n\nAt the start of procedure baseline vitals will be recorded as per our unit's policy. Research medication will be administered 3 minutes prior to administration of other medications. Neither the patient nor the medical staff including the endoscopist will be aware of the contents of the vial. Conscious sedation will be achieved using a combination of intravenous midazolam and fentanyl as standard sedative. Rarely, additional diphenhydramine will be given, on the basis of the judgment of the endoscopist. During the procedure vital signs including oxygen saturation will be monitored at 3-5 minute interval. Procedure related complications, including hypotension, desaturation and cardiac arrhythmia will be managed according to our endoscopy unit policy and protocols.\n\nFollowing the procedure, the nurse and the fellow or the attending will individually rate the quality if sedation on a ten-point Likert scale. Qualitative assessment will also be made (Under-sedated, adequately sedated, or over-sedated).\n\nRecovery time will be recorded.\n\nDay Following the Colonoscopy Twenty-four hour discharge a follow up call will be made and the patients will be asked to evaluate the level of sedation on a 10-point scale (1, inadequate; 10 completely without discomfort); pain (1, no pain; 10 severe pain), and amnesia (10, no memory of the procedure; 1 complete memory)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-64 years undergoing screening, surveillance, diagnostic and therapeutic colonoscopy\n* Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at least 3 days per week for more than 3 months\n\nExclusion Criteria:\n\n* Inability to execute informed consent\n* Allergy to Diphenhydramine, fentanyl or midazolam\n* Known or suspected pregnancy\n* Endoscopic procedure without sedation\n* Patient scheduled to have other endoscopic procedures on the same day\n* Prior alimentary tract surgery\n* Severe cardiopulmonary disease (ASA IV)\n* Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure'}, 'identificationModule': {'nctId': 'NCT01967433', 'briefTitle': 'Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Use of Diphenhydramine as an Adjunctive Sedative for Colonoscopy in Patients Chronically on Opioids', 'orgStudyIdInfo': {'id': 'DAASIPCO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diphenhydramine', 'description': 'Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives', 'interventionNames': ['Drug: Diphenhydramine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Diphenhydramine', 'type': 'DRUG', 'otherNames': ['Benadryl'], 'armGroupLabels': ['Diphenhydramine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline', '0.9% sodium chloride'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Salman Nusrat, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oklahoma'}, {'name': 'Mohammad Madhoun, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of Oklahoma Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}