Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-29 @ 10:10 PM
Study NCT ID:
NCT01325493
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2011-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013168', 'term': 'Spondylolisthesis'}, {'id': 'D006930', 'term': 'Hyperalgesia'}, {'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JFINKEL@childrensnational.org', 'phone': '2024764867', 'title': 'Julia Finkel', 'organization': "Children's National Health System"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Patient sex and ethnicity could have led to analytical bias.'}}, 'adverseEventsModule': {'timeFrame': 'the duration of the study (96 hrs) post surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine', 'description': 'Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Saline', 'description': 'Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Allergy', 'notes': 'Morphine allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Morphine Equivalent Consumption (mg/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}], 'classes': [{'title': '24 hrs after surgery', 'categories': [{'measurements': [{'value': '1.3', 'spread': '.3', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '.42', 'groupId': 'OG001'}]}]}, {'title': '48 hrs after surgery', 'categories': [{'measurements': [{'value': '1.28', 'spread': '.26', 'groupId': 'OG000'}, {'value': '1.275', 'spread': '.31', 'groupId': 'OG001'}]}]}, {'title': '72 hrs after surgery', 'categories': [{'measurements': [{'value': '.89', 'spread': '.55', 'groupId': 'OG000'}, {'value': '.93', 'spread': '.36', 'groupId': 'OG001'}]}]}, {'title': '96 hrs after surgery', 'categories': [{'measurements': [{'value': '.57', 'spread': '.44', 'groupId': 'OG000'}, {'value': '.38', 'spread': '.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 24, 48, 72, 96 hours post operatively', 'description': 'Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}], 'classes': [{'title': '24 hrs after surgery', 'categories': [{'measurements': [{'value': '.73', 'spread': '.68', 'groupId': 'OG000'}, {'value': '.75', 'spread': '.73', 'groupId': 'OG001'}]}]}, {'title': '48 hrs after surgery', 'categories': [{'measurements': [{'value': '.62', 'spread': '.8', 'groupId': 'OG000'}, {'value': '.54', 'spread': '.85', 'groupId': 'OG001'}]}]}, {'title': '72 hrs after surgery', 'categories': [{'measurements': [{'value': '.38', 'spread': '.45', 'groupId': 'OG000'}, {'value': '.3', 'spread': '.84', 'groupId': 'OG001'}]}]}, {'title': '96 hrs after surgery', 'categories': [{'measurements': [{'value': '.24', 'spread': '.43', 'groupId': 'OG000'}, {'value': '.21', 'spread': '.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24, 48, 72, 96 hours post operatively', 'description': 'Sedation scores 0 = completely awake\n\n1. = sleepy but responds appropriately\n2. = somnolent but arouses to light stimuli\n3. = asleep but responsive to deeper physical stimuli\n4. = asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery.', 'unitOfMeasure': 'Sedation Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}], 'classes': [{'title': '24 hrs after surgery', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.55', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '48 hrs after surgery', 'categories': [{'measurements': [{'value': '4.53', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': '72 hrs after surgery', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.48', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '96 hrs after surgery', 'categories': [{'measurements': [{'value': '4.48', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24, 48, 72, 96 hours post operatively', 'description': 'Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.', 'unitOfMeasure': 'pain score at rest', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score During Cough.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}], 'classes': [{'title': '24 hrs after surgery', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': '48 hrs after surgery', 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': '72 hrs after surgery', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': '96 hrs after surgery', 'categories': [{'measurements': [{'value': '5.15', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24, 48, 72, 96 hours post operatively', 'description': 'Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.', 'unitOfMeasure': 'pain score at cough', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine', 'description': 'Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}, {'id': 'FG001', 'title': 'Saline', 'description': 'Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'loss of neuromonitoring signals', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Allergy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine', 'description': 'Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}, {'id': 'BG001', 'title': 'Saline', 'description': 'Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '18'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '18'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'American Society of Anesthesiology classification', 'classes': [{'title': 'ASA 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'ASA 2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'ASA 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ASA classifications: ASA Physical Status 1 - A normal healthy patient ASA Physical Status 2 - A patient with mild systemic disease ASA Physical Status 3 - A patient with severe systemic disease', 'unitOfMeasure': 'participants'}], 'populationDescription': 'ASA classifications: ASA Physical Status 1 - A normal healthy patient ASA Physical Status 2 - A patient with mild systemic disease ASA Physical Status 3 - A patient with severe systemic disease'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2011-02-25', 'resultsFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2011-03-28', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-01', 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Equivalent Consumption (mg/kg)', 'timeFrame': 'at 24, 48, 72, 96 hours post operatively', 'description': 'Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.'}], 'secondaryOutcomes': [{'measure': 'Sedation Score', 'timeFrame': '24, 48, 72, 96 hours post operatively', 'description': 'Sedation scores 0 = completely awake\n\n1. = sleepy but responds appropriately\n2. = somnolent but arouses to light stimuli\n3. = asleep but responsive to deeper physical stimuli\n4. = asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery.'}, {'measure': 'Pain Score at Rest', 'timeFrame': '24, 48, 72, 96 hours post operatively', 'description': 'Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.'}, {'measure': 'Pain Score During Cough.', 'timeFrame': '24, 48, 72, 96 hours post operatively', 'description': 'Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['opioid tolerance', 'hyperalgesia', 'scoliosis', 'pupillometry'], 'conditions': ['Idiopathic Scoliosis', 'Spondylolisthesis']}, 'referencesModule': {'references': [{'pmid': '24809838', 'type': 'DERIVED', 'citation': 'Pestieau SR, Finkel JC, Junqueira MM, Cheng Y, Lovejoy JF, Wang J, Quezado Z. Prolonged perioperative infusion of low-dose ketamine does not alter opioid use after pediatric scoliosis surgery. Paediatr Anaesth. 2014 Jun;24(6):582-90. doi: 10.1111/pan.12417.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n1\\. Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject is 10 to 18 years of age\n2. The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)\n3. The subject is scheduled for elective posterior spinal fusion and instrumentation.\n4. The subject's parent/legally authorized guardian has given written informed consent to participate\n\nExclusion Criteria:\n\n1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia\n2. The subject is pregnant or nursing.\n3. The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests\n4. The subject has a known or suspected allergy to morphine, remifentanil or ketamine\n5. The subject is an ASA classification of 4 or greater (See Appendix I)\n6. The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)\n7. The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump\n8. The subject had a recent opioid exposure (within 1 month of surgery)\n9. The subject is obese (body mass index \\>30kg/m2)\n10. The subject is planned for elective postoperative ventilation\n11. The subject has a known ocular disease not permitting pupillometric examination\n12. The subject has used any investigation products in the past 30 days"}, 'identificationModule': {'nctId': 'NCT01325493', 'acronym': 'KPSF', 'briefTitle': 'Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia', 'organization': {'class': 'OTHER', 'fullName': "Children's National Research Institute"}, 'officialTitle': 'Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents', 'orgStudyIdInfo': {'id': '4735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Normal Saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine', 'description': 'ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketanest, Ketaset, and Ketalar'], 'description': 'ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h', 'armGroupLabels': ['Ketamine']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['0.90% NaCl'], 'description': 'Normal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Pestieau Sophie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's National Research Institute"}, {'name': 'Finkel C Julie, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's National Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Julia Finkel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Research', 'investigatorFullName': 'Julia Finkel', 'investigatorAffiliation': "Children's National Research Institute"}}}}