Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT03063359
Status:
TERMINATED
Last Update Posted:
2020-12-31
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'The new pain protocols imposed by the HAS make it difficult to include new patients in the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-29', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the value of the pain feeling', 'timeFrame': '45 minutes', 'description': 'Assessment of the value of the pain feeling measured by visual analogic scale'}], 'secondaryOutcomes': [{'measure': 'Delay in treatment efficacy', 'timeFrame': 'up to 45 minutes', 'description': 'Delay in treatment efficacy measured by a reduction of pain (1 point) assessed by visual analogic scale from the administration of the treatement.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['traumatic pain', 'children', 'fentanyl', 'intranasal use'], 'conditions': ['Pain, Acute']}, 'descriptionModule': {'briefSummary': "Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments.\n\nTo manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it.\n\nThe ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged between 4 years old and 15,3 years old\n* Acute pain in traumatic context with a suspicion of fracture for patient \\<7years old : feeling Pain \\>6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not \\<10 points)\n* For patients \\>7 years old : feeling pain \\>6 points and defined thanks to a visual analogic scale\n* Informed consent form signed by parents\n* Beneficiary of an european health protection\n\nExclusion Criteria:\n\n* Antalgic ( II or III) within 4 hours before the inclusion\n* Allergic or non-indication of fentanyl\n* Allergic or contraindication of morphine sulfate\n* Pre existing peripheral intravenous catheter\n* Traumatic brain injury\n* Nasal traumatic'}, 'identificationModule': {'nctId': 'NCT03063359', 'acronym': 'FINDOL', 'briefTitle': 'Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study', 'orgStudyIdInfo': {'id': '9732'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal fentanyl + Oral placebo', 'description': 'Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.', 'interventionNames': ['Drug: Intranasal fentanyl + Oral Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral morphine + Intranasal placebo', 'description': 'Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.', 'interventionNames': ['Drug: Oral Morphine + Intranasal Placebo']}], 'interventions': [{'name': 'Intranasal fentanyl + Oral Placebo', 'type': 'DRUG', 'otherNames': ['Intranasal Fentanyl + Oral NaCl'], 'description': 'Administration of intranasal fentanyl (1.5µg/kg) and Oral placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.', 'armGroupLabels': ['Intranasal fentanyl + Oral placebo']}, {'name': 'Oral Morphine + Intranasal Placebo', 'type': 'DRUG', 'otherNames': ['Oral Morphine + Intranasal NaCl'], 'description': 'Administration of oral morphine (0,4mg/kg) and intranasal placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.', 'armGroupLabels': ['Oral morphine + Intranasal placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'University hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Gaël GG GUYON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}