Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-25 @ 6:36 PM
Study NCT ID:
NCT02437669
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2015-05-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dst2141@columbia.edu', 'phone': '212-305-9825', 'title': 'Daniel S. Tsze, MD, MPH', 'organization': 'Columbia University College of Physicians and Surgeons'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Intranasal Hydromorphone', 'description': 'Children who received intranasal hydromorphone', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 22, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sleepy, drowsy, or tired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bad taste in mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheaded, dizzy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Warm sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Score on Faces Pain Scale - Revised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Hydromorphone', 'description': 'Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg.\n\nHydromorphone: To be administered by intranasal route using mucosal atomization device.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents "very much pain" (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Decrease in pain score one hour after terminal dose of intranasal hydromorphone administered'}, {'type': 'SECONDARY', 'title': 'Number of Minor Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Hydromorphone', 'description': 'Children who received intranasal hydromorphone'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'description': 'Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis.', 'unitOfMeasure': 'Minor adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Major Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Hydromorphone', 'description': 'Children who received intranasal hydromorphone'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'description': 'Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone.', 'unitOfMeasure': 'Major adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Verbal Numeric Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Hydromorphone', 'description': 'Children who received intranasal hydromorphone'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Pain was measured using the Verbal Numerical Rating Scale (VNRS). The VNRS is a self-reported measure of pain that is administered verbally by asking a patient to rate their pain on a scale from 0 to 10, with 0 representing no pain, and 10 representing maximum pain. More information about the VNRS in children can be found here: https://bit.ly/2VZ7aWU', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Decrease in pain score one hour after terminal dose of intranasal hydromorphone administered'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intranasal Hydromorphone', 'description': 'Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg.\n\nHydromorphone: To be administered by intranasal route using mucosal atomization device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intranasal Hydromorphone', 'description': 'Children who received intranasal hydromorphone'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline pain score', 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents "very much pain" (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-16', 'size': 69562, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-09T00:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-07', 'studyFirstSubmitDate': '2015-05-05', 'resultsFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-17', 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on Faces Pain Scale - Revised', 'timeFrame': '1 hour', 'description': 'Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents "very much pain" (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM'}], 'secondaryOutcomes': [{'measure': 'Number of Minor Adverse Events', 'timeFrame': '6 hours', 'description': 'Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis.'}, {'measure': 'Number of Major Adverse Events', 'timeFrame': '6 hours', 'description': 'Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone.'}, {'measure': 'Score on Verbal Numeric Rating Scale', 'timeFrame': '1 hour', 'description': 'Pain was measured using the Verbal Numerical Rating Scale (VNRS). The VNRS is a self-reported measure of pain that is administered verbally by asking a patient to rate their pain on a scale from 0 to 10, with 0 representing no pain, and 10 representing maximum pain. More information about the VNRS in children can be found here: https://bit.ly/2VZ7aWU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intranasal', 'Hydromorphone', 'Pediatric', 'Emergency department'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '30902361', 'type': 'RESULT', 'citation': 'Tsze DS, Pan SS, DePeter KC, Wagh AM, Gordon SL, Dayan PS. Intranasal hydromorphone for treatment of acute pain in children: A pilot study. Am J Emerg Med. 2019 Jun;37(6):1128-1132. doi: 10.1016/j.ajem.2019.03.013. Epub 2019 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It has not been previously studied in children, but may be a viable option for effectively and safely reducing pain in children by administering an analgesic by the intranasal route.\n\nThis study will be a prospective, open-label pilot study of intranasal hydromorphone in children with moderate to severe acute pain presenting to the pediatric emergency department. The investigators aim to describe the amount of pain reduction associated with intranasal hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with a clinically meaningful improvement in acute pain.', 'detailedDescription': "Primary Aim: Determine the change in pain intensity in children with moderate to severe pain who receive intranasal hydromorphone one hour after administration.\n\nSecondary Aim(s): Describe the incidence of minor and major adverse events associated with intranasal hydromorphone in children with acute pain.\n\nThe investigators will assess the patient's pain at baseline (prior to study drug administration), then after study drug administration: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and then every 30 minutes thereafter until 6 hours; administration of non-protocolized rescue medication administration (i.e. administered after first two rescue doses of IN hydromorphone); or discharge from emergency department (whichever comes first). The pain score at 60 minutes will be the primary outcome.\n\nThe investigators will evaluate qualitative improvement in pain intensity at 15- and 30-minutes after study drug administration. If there is no improvement, or worsening of pain intensity, at each assessment, an additional rescue dose rescue dose of intranasal hydromorphone will be administered. After 60 minutes, the treating physician may administer any additional rescue medications at their discretion to treat the child's pain.\n\nThe patient will be assessed for minor and major adverse events for the duration of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 4 to 17 years old, inclusive\n* Moderate to severe pain (i.e. FPS-R or vNRS score of 4 or more)\n* Requires parenteral opioid analgesic to treat their pain, as decided by treating physician\n\nExclusion Criteria:\n\n* Allergy or known contraindication to receiving opioids\n* Receipt of any opioid or benzodiazepine within preceding 6 hours\n* Presence of intranasal obstruction that cannot be cleared readily\n* Cannot speak English or Spanish\n* Patient unlikely to be able to complete self-report measures of pain or questionnaires\n* Known liver or kidney problems\n* Currently critically ill\n* Chronic pain condition (e.g. sickle cell disease, fibromyalgia)'}, 'identificationModule': {'nctId': 'NCT02437669', 'briefTitle': 'Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.', 'orgStudyIdInfo': {'id': 'AAAP5709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal hydromorphone', 'description': 'Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg.', 'interventionNames': ['Drug: Hydromorphone']}], 'interventions': [{'name': 'Hydromorphone', 'type': 'DRUG', 'otherNames': ['Dilaudid'], 'description': 'To be administered by intranasal route using mucosal atomization device.', 'armGroupLabels': ['Intranasal hydromorphone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Morgan Stanley Children's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Daniel Tsze, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics at CUMC', 'investigatorFullName': 'Daniel S Tsze, MD, MPH', 'investigatorAffiliation': 'Columbia University'}}}}