Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-03-01 @ 6:27 AM
Study NCT ID:
NCT03233035
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
2017-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Ketamine Intra Nasal Traumatology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Ketamine versus placebo as a double blind study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double Blind Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-30', 'studyFirstSubmitDate': '2017-05-14', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of patients who need rescue opiods in the two groups', 'timeFrame': '30 minutes', 'description': 'the need for rescue opioids during ED stay'}], 'secondaryOutcomes': [{'measure': 'Intolerance to treatement and adverse events', 'timeFrame': '30 minutes and at 120 minutes', 'description': 'Noticing any sign of intolerance due to treatement : Dizziness , Vomiting..'}, {'measure': 'Percentage of patients with VAS <30 mm at discharge', 'timeFrame': '120 minutes', 'description': 'percentage of patients discharged from the ED with VAS \\<30.'}, {'measure': 'Number and percentage of patients who required non opiods analgesics', 'timeFrame': '30 minutes', 'description': 'Requirement of non-opioids analgesic agents'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine-Intranasal-Acute pain-Emergency departement'], 'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine analgesic agents in patients with moderate to severe pain in the ED in reducing the need for opioid or non opioids analgesic agents.', 'detailedDescription': 'Intranasal ketamine for treatment of acute pain in the emergency department : A randomized controlled trial\n\nIntroduction :\n\nPain is the most common complaint for emergency department (ED) visits \\[1\\].The provision of adequate, safe, and timely analgesia is a core component of patient care in the emergency department (ED). Ketamine is a noncompetitive Nmethyl- D-aspartate and glutamate receptor antagonist that decreases central sensitization, "wind-up" phenomena, and pain memory \\[2,3\\].\n\nAt subdissociative doses (0.1 to 0.6 mg/kg; most commonly 0.3 mg/kg) maintains potent analgesic and amnestic effects that are accompanied by preservation of protective airway reflexes, spontaneous respiration, and cardiopulmonary stability \\[4-6\\].\n\nIntranasal route ….\n\nObjective of the study :\n\nTo evaluate the efficacy and safety of early administration of low-dose intranasal ketamine analgesic agents in patients with moderate to severe pain in the ED in reducing the need for opioid or class III analgesic agents.\n\nMaterials and Methods :\n\nStudy design :\n\nIt is a ramdomized, prospective, double blind, controlled, multicentric trial. The study is registered with clinical.tria.gov (…….).\n\nStudy Setting and Selection of Participants :\n\nThe trial is conducted in three community teaching hospitals :\n\n* Emergency department, fattouma bourguiba university hospital, monastir, tunisia\n* Emergency department, sahloul university hospital, sousse, tunisia\n* Emergency department, farhat hached university hospital, sousse, tunisia\n\nED principal investigators maintain the randomization list, which is generated before the start of the study, prepare the medication, and deliver it to the treating physician in a blinded manner.\n\nInclusion criteria :\n\nThe study includes patients aged 18 to 80 years who presented to the ED with acute limb trauma pain with a visual analogue scale (VAS) of 5 or more on a standard 11- point (0 to 10). An informed consent is necessary.\n\nExclusion criteria :\n\n* Pregnancy,\n* Breast-feeding,\n* Altered mental status,\n* Allergy to ketamine or morphine or\n* Weight less than 46 kg or greater than 115 kg,\n* Unstable vital signs (systolic blood pressure \\<90 or \\>180 mm Hg, pulse rate \\<50 or \\>150 beats/min, and respiration rate \\<10 or \\>30 breaths/min),\n* Medical history of acute head or eye injury, seizure, intracranial hypertension, chronic pain, severre renal or hepatic insufficiency,\n* Alcohol or drug abuse,\n* Psychiatric illness,\n* Recent (4 hours before) analgesic agent use.\n\nProtocol :\n\nIn the triage area, each patient having the inclusion criteria receives 25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril or 0.5 mL of normal saline solution in one pulverisation per nostril as a placebo according to the predetermined randomization list. None of the treating physician or nurses is aware about the medication received. In all patients included, the investigators collect vital signs ; demographic and clinical data.\n\nStudy investigators record VAS, and adverse effects at 15, 30, 60, 90, and 120 minutes.\n\nAt 30 minutes, if patients report a pain numeric rating scale score of 5 or greater and request additional pain relief, titrated morphine is administered as a rescue analgesic with a dose of 0.1 mg/Kg repeated every 3 to 5 minutes if the pain numeric rating scale score is still greater or equal to 3.\n\nAll data recorded on data collection sheets, including sex, demographics, medical history, and vital signs, were entered into SPSS (version 20.0; IBM Corp) by the research manager.\n\nPatients\'s informed consent is obtained. The ethic commitee of our institution approved the study.\n\nEndpoints :\n\nPrimary endpoints :\n\n\\- Need for rescue opioids during ED stay\n\nSecondary endpoints :\n\n* requirement of non-opioids analgesic agents.\n* percentage of patients discharged from the ED with VAS \\<30.\n* Safety : adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study includes patients aged 18 to 80 years who presented to the ED with acute limb trauma pain with a visual analgesic scale (VAS) of 5 or more on a standard 11- point (0 to 10). An informed consent is necessary.\n\nExclusion Criteria:\n\n* \\- Pregnancy,\n* Breast-feeding,\n* Altered mental status,\n* Allergy to ketamine or morphine or\n* Weight less than 46 kg or greater than 115 kg,\n* Unstable vital signs (systolic blood pressure \\<90 or \\>180 mm Hg, pulse rate \\<50 or \\>150 beats/min, and respiration rate \\<10 or \\>30 breaths/min),\n* Medical history of acute head or eye injury, seizure, intracranial hypertension, chronic pain, severre renal or hepatic insufficiency,\n* Alcohol or drug abuse,\n* Psychiatric illness,\n* Recent (4 hours before) analgesic agent use.'}, 'identificationModule': {'nctId': 'NCT03233035', 'acronym': 'Ket', 'briefTitle': 'Low Dose Ketamine Intra Nasal Traumatology', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Intranasal Ketamine for Treatment of Acute Pain in the Emergency Department : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Ket-Int-Nas-TR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'Intranasal placebo pulverisation', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine group', 'description': 'Intranasal ketamine pulverisation', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': '25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril is received', 'armGroupLabels': ['Ketamine group']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['normal saline solution'], 'description': '0.5 mL of normal saline solution as a placebo in one pulverisation per nostril', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Emergency Department Monastir, Tunisia 5000', 'country': 'Tunisia', 'facility': 'Nouira Samir', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}, {'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Emergency department of university hospital Fattouma Bourguiba of Monastir', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Nouira Semir, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'university Hospital of Monastir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}