[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530047":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":51,"studyPopulation":41,"armGroups":52,"interventions":64,"overallOfficials":72,"centralContacts":77,"locations":41,"responsibleParty":88,"collaborators":41,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":41,"maxAge":99,"enrollmentInfo":100,"targetDuration":41,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":41,"overallStatus":109,"whyStopped":41,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":41},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell in children","efficacy of the analgesia at 30 minutes after IN injection, in children with SCD presenting to the pediatric ED with a severe VOC with Pain relief is defined as EVENDOL score ≤ 5\u002F15 or NRS-11 score ≤ 3\u002F10","at 30 minutes",[14,17,21,25,29,33,37],{"measure":15,"description":15,"timeFrame":16},"Proportion of children relieved (EVENDOL ≤ 5\u002F15 or NRS-11 ≤ 3\u002F10) at 10, 20, 40, 50 and 60 minutes after the IN injection inclusion","at 60 minutes",{"measure":18,"description":19,"timeFrame":20},"Proportion of children with a moderate pain (EVENDOL ≤ 9\u002F15 or NRS-11 ≤ 6\u002F10) at 10, 20, 30, 40, 50 and 60 minutes after the IN injection","Proportion of children relieved (EVENDOL ≤ 5\u002F15 or NRS-11 ≤ 3\u002F10) at 10, 20, 40, 50 and 60 minutes after the IN spray;","EVENDOL ≤ 5\u002F15 or NRS-11 ≤ 3\u002F10 at 10, 20, 40, 50 and 60 minutes",{"measure":22,"description":23,"timeFrame":24},"To demonstrate that {IN Sufentanil +IV morphine(as a standard of care)} procedure, when compared to {IN Placebo + IV morphine (as a standard of care)} procedure, is able to decrease the level of morphine consumption","Morphine consumption (mg). Assessed morphine consumption after treatment initiation, until 60 minutes","from randomisation to 60 minutes after",{"measure":26,"description":27,"timeFrame":28},"To demonstrate the safety of the {IN Sufentanil +IV morphine} procedure, when compared to {IN Placebo + IV morphine } procedure, that is an absence of increase rate of hemodynamic and non-hemodynamic side effects of opiace","Rates of hypotension, hypoxia, bradycardia, respiratory distress, headache, nausea, vomiting, sleepiness and itchiness until 4 hours after the IN injection","until 4 hours after the IN injection",{"measure":30,"description":31,"timeFrame":32},"To evaluate the safety of all children aged 0-18 years","This outcome is defined by the proportion of patients with at least one adverse events during the medical care, until 4 hours after treatment initiatio","From randomisaton to 4 hours after",{"measure":34,"description":35,"timeFrame":36},"To demonstrate that the {IN Sufentanil +IV morphine (as a standard of care)} procedure, when compared to {IN Placebo + IV morphine (as a standard of care)} procedure, is able to improve the management of a VOC episode","Rate of admission after the ED visit","after 4 hours of randomisation",{"measure":38,"description":39,"timeFrame":40},"To demonstrate that the {IN Sufentanil +IV morphine (as a standard of care)} procedure, when compared to {IN Placebo + IV morphine(as a standard of care)} procedure, is able to decrease the proportion of VOC complications","Rate of Acute chest syndrome: at hospital discharge Rate of admission in ICU, invasive ventilation, non-invasive ventilation, oxygene therapy: at hospital discharge Rate of Transfusion: at hospital discharge Rate of death: at hospital discharge","at hospital discharg, after 4 hours after randomisation",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":48},"DOUBLE",[49,50],"PARTICIPANT","INVESTIGATOR","Sufentanil is a powerful opioid analgesic used intravenously by emergency physicians for the sedation of intensive care, intubated and ventilated patients. It is therefore already present in the pharmacopoeia of emergencies. As the duration of action of inztranasal Sufentanil is too short to completely replace the IV morphine, a very promising approach would be to use it during the initial phase of the management of severe pain in children with painful sickle cell crisis while waiting for a venous access.\n\nThe INVOPE trial is a phase III trial evaluating the intranasal sufentanil in sickle cell disease children with severe VOC.\n\nThe INVOPE trial is a randomized controlled, multicenter, double blind, two parallel-group in a 1:1 ratio, placebo-controlled superiority trial comparing the analgesic efficacy of the sufentanil IN + standard care IV morphine \u002F versus placebo IN + IV morphine as soon as possible.\n\nChildren will be randomized in two groups:\n\n* Experimental group: IN Sufentanil procedure with IV administration of morphine as soon as possible\n* Control group : IN placebo IN procedure with IV administration of morphine as soon as possible\n\nThe objective of this trial is to compare a procedure consisting in IN Sufentanil followed by IV morphine, when compared to IN placebo followed by IV morphine alone, in children with severe vaso-occlusive crisis.",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Sufentanil IN + Morphine IV","EXPERIMENTAL","Intranasal Sufentanil + IV morphine:",[58],"Drug: Sufentanil",{"label":60,"type":61,"description":62,"interventionNames":63},"Placebo IN + Morphine IV","PLACEBO_COMPARATOR","Placebo of Sufentanil administered intranasally (IN) . One single administration +IV morphine similar to the experimental arm:",[58],[65],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"DRUG","Sufentanil","Administration of intranasal sufentanil",[60,54],[71],"sufentanil IN + morphine IV",[73],{"name":74,"affiliation":75,"role":76},"Camille AUPIAIS, Pre","Assistance Publique des Hopitaux de Paris","PRINCIPAL_INVESTIGATOR",[78,84],{"name":79,"role":80,"phone":81,"phoneExt":82,"email":83},"Camille AUPIAIS, Per","CONTACT","01 48 02 55 55","3 42 29","camille.aupiais@aphp.fr",{"name":85,"role":80,"phone":86,"phoneExt":41,"email":87},"Houda ALLALOU","01 48 95 74 07","houda.allalou@aphp.fr",{"type":89,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100530047","phase-3-intranasal-sufentanil-for-analgesia-of-severe-sickle-cell-vaso-occlusive-pain-crisis-in-the-pediatric-100530047",false,"NCT06181695","Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric","Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric Emergency Department: a Double Blind Randomized Versus Placebo Controlled Trial","INVOPE","Inclusion Criteria:\n\nAt inclusion visit:\n\n* Sickle-cell disease = Hemoglobin SS or SC or Sß-thalassemia\n* Age \\\u003C 18 years old\n* Weight \\> 10 kgs\n* Registered with the social security scheme (or State Medical Aid - AME) or his\u002Fher beneficiaries\n* Informed consent of the holder (s) of the exercise of parental authority\n* Age \\\u003C 18 years old\n\nAt randomisation visit\n\n* Presenting to the ED with vaso-occlusive crisis: migratory bone pain, which may occur in the limbs, spine, thorax, pelvis, skull; or crisis known as such by the patient.\n* Severe pain determined at triage, defined as:\n\n  * EVENDOL ≥ 10\u002F15 in children aged 0-8 years or\n  * NRS-11 ≥ 7\u002F10 in children aged 8 years to less than 18 years\n* Informed consent of the holder (s) of the exercise of parental authority signed at inclusion visit\n\nExclusion Criteria:\n\n* At inclusion visit\n\n  * Known cirrhosis\n  * End-stage renal disease requiring kidney dialysis\n  * Known hypersensitivity or contraindication to sufentanil or any of the excipients\n  * Contraindication to morphine\n  * Facial malformation, epistaxis, blocked or traumatised nose\n  * Severe asthma\n  * Patient's or parent's refusal to participate\n  * Participation in another interventional trial\n  * Parents who do not speak French\n\nAt randomization visit\n\n* Known cirrhosis\n* End-stage renal disease requiring kidney dialysis\n* Known hypersensitivity or contraindication to sufentanil or any of the excipients\n* Contraindication to morphine\n* Facial malformation, epistaxis, blocked or traumatised nose\n* Severe asthma\n* Patient's or Parent's refusal to participate or withdrawal of parental consent\n* Participation in another interventional trial\n* Patient has already been randomised to the INVOPE trial during a previous VOC\n* Strong opioids received \\\u003C6 hours (morphine, oxycodone, hydromorphone, fentanyl, sufentanil, nalbuphine)\n* Respiratory failure (tachypnea; bradypnea; paradoxical breathing; grunting; head-bobbing; nasal flaring; retractions (subcostal, suprasternal, intercostal, sternal))\n* Oxygen saturations below 95% on initial assessment\n* Pneumonia requiring oxygen therapy\n* Hemodynamic disorders: tachycardia, hypotension\n* Altered conscious state as defined by a Glasgow Coma score less than 15\n* Positive urinary pregnancy test for woman of childbearing potential (postpubertal female with sexual activity)\n* Nasal or sinus surgery within 6 months before randomisation\n* High fever \\> 39°C\n* Sign of intolerance of acute anaemia\n* Description by the patient (or the parents) of the unusual nature of the attack","ALL","18 Years",{"count":101,"type":102},182,"ESTIMATED","INTERVENTIONAL",[105],"PHASE3","Sickle cell disease (SCD) is characterized by an abnormal hemoglobin, the main protein in the red blood cell. From the first months of life, acute obstruction of the vessels of the microcirculation manifests as intense and unpredictable recurrent episodes of severe pain. In the Emergency Department (ED), patients presenting with a vaso-occlusive crisis (VOC) required a rapid evaluation and administration of pain relief therapies and hydration.\n\nthis strategy is based on an intranasal (IN) administration of Sufentanil at the initial management of children with VOC, followed by morphine intravenous (IV) relay as soon as possible, compared to the usual care procedure with IV morphine as soon as possible.\n\nThe hypothesis is that the use of this IN opioid at the beginning of the management of children with VOC can reduce the time before being pain relieved. Indeed, the IN administration make it easier and faster to administer.",[108],"Vaso-occlusive Crisis","NOT_YET_RECRUITING","2023-12-12",{"date":112,"type":113},"2023-12-26","ACTUAL",{"date":115,"type":102},"2024-05-02",{"date":117,"type":102},"2027-05-29",{"name":5,"class":6}]