[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatology\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatology":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100590525","phase-2-sufentanil-versus-ketamine-intranasally-in-the-management-of-severe-acute-trauma-related-pain-in-children-100590525",false,"NCT06968546","Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.","Randomized Controlled Study Comparing Sufentanil and Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.","SUF-KET-PED","Inclusion Criteria:\n\n* Children aged 6 to 17 years inclusive, under 18 years old, weighing more than 10kg, and requiring analgesia for the management of acute pain\n* Presenting with pain assessed as severe using a validated pain scale (VAS \\> 6\u002F10)\n* Acute traumatic lime injury\n* Pain caused by trauma, excluding thoracic trauma with dyspnea and abdominal pain\n* Obtaining written and signe informed consent from one of the two parents or legal guardians\n* Affiliation with a social security system\n* Hemodynamically stable\n* For post-menarche girls: negative urine pregnancy test and effective contraception, in accordance with national regulations\n\nExclusion Criteria:\n\n* Patient in a state of immediate life-threatening distress\n* Parents who don't understand and\u002For don't speak French\n* Known hypersensitivity to opiods\n* Allergy to one of the study treatments\n* History of epilepsy or known psychiatric illness\n* History of respiratory, cardiac or renal insufficiency\n* Use of serotonergic antidepressants\n* Any child with an ongoing respiratory condition (asthma, laryngitis)\n* Thoracic trauma\n* Use of opioids within the 4 hours prior to arrival in the ermergency department\n* Any child with an ongoing respiratory condition (asthma, laryngitis)\n* Thoracic trauma\n* Use of opioids within the 4 hours prior to arrival in the ermergency department\n* History of head, abdominal, or spinal trauma\n* Confirmed pregnancy\n* History of toxic substance use\n* Facial or nasal trauma\n* Whithdrawal of informed consent from the parents or legal guardian","ALL","6 Years","17 Years",{"count":21,"type":22},116,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Pain is one of the most common reasons for children to attend emergency departments, particularly following traumatic injuries such as fractures, sprains, or contusions. Despite advances in medical care, severe acute pain in children is still sometimes inadequately treated. One important reason is that intravenous pain medication can be technically difficult, stressful, or delayed in paediatric patients.\n\nIntranasal drug administration, which involves spraying medication into the nose, offers a rapid and needle-free way to relieve pain and is increasingly used in paediatric emergency care. Two medications can be administered through this route: ketamine and sufentanil. Intranasal ketamine is already widely used in children for pain management. Sufentanil is a potent opioid analgesic commonly used in adults and in anaesthesia but has been much less studied in children when administered intranasally.\n\nThe aim of this study is to compare the effectiveness and safety of intranasal sufentanil and intranasal ketamine in children aged 6 to 17 years who present to the emergency department with severe traumatic limb pain. Both medications will be given in addition to standard care, including the routine use of an oxygen-nitrous oxide gas mixture (MEOPA), which is commonly used to reduce pain and anxiety in children.\n\nChildren who take part in the study will be randomly assigned to receive either intranasal sufentanil or intranasal ketamine. Pain levels will be assessed at regular time points after medication administration using age-appropriate pain scales. Sedation level and possible side effects will also be closely monitored for a short period following treatment.\n\nThe hypothesis of this study is that intranasal sufentanil will provide greater pain relief than intranasal ketamine 30 minutes after administration, without increasing the risk of adverse effects, when both are used alongside standard emergency care.\n\nThe results of this study are expected to improve knowledge about fast, effective, and non-invasive pain relief strategies for children in emergency settings and may help optimise future pain management protocols in paediatric emergency care.",[28,29,30,31,32,33,34],"Traumatology","Wounds and Injury","Fractures Bone","Analgesia","Pain","Pain Management","Acute Pain","NOT_YET_RECRUITING","2026-01-26",{"date":38,"type":39},"2026-01-28","ACTUAL",{"date":41,"type":22},"2026-02-05",{"date":43,"type":22},"2028-03-31",{"name":45,"class":46},"Fondation Lenval","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100491286","phase-2-influence-of-an-anti-osteoporotic-drug-on-healing-after-surgical-repair-of-chronic-rotator-cuff-lesions-of-the-shoulder-100491286","NCT05677152","Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder","Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial","ZORRO","Inclusion Criteria\n\n* Age between 50 and 70 years\n* Magnetic resonance imaging verified rotator cuff tear (within 6 month prior to surgery)\n* Rupture size with a maximum diameter of 3 cm\n* Willingness to participate in the study\n* Willingness to participate in a unified physiotherapy with use of a shoulder abduction pad for four weeks postoperativel\n\nExclusion Criteria:\n\n* Patients younger than 50 or older than 70 years of age\n* Pregnancy\n* Known allergy to zoledronic acid or other components of the medicinal product\n* Previous fracture of the affected shoulder\n* Previous surgery of the affected shoulder\n* Previous or existing bacterial infection of the affected shoulder\n* Rupture of more than two tendons in the affected shoulder (massive rotator cuff tear)\n* Isolated subscapularis tendon tear\n* Presence of glenohumeral osteoarthritis (Hamada type 3 or higher)\n* Diabetes mellitus (fasting glucose ≥ 126 mg\u002Fdl, HbA1C ≥ ZORRO Version Draft1.0\u002F09.05.2022 Page 6 of 42 6.5%)\n* Malignant tumor disease\n* Pathological dental status\n* Known disease that interferes with bone metabolism\n* Concomitant diseases that do not permit general anesthesia\n* Previous therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide)\n* Epilepsy\n* Claustrophobia\n* Chronic alcohol abuse\n* Drug abuse","50 Years","70 Years",{"count":59,"type":22},80,[25],"This is a prospective, single-center, placebo-controlled, non-comparative, phase II study to evaluate the influence of an adjuvant, intravenous therapy with zoledronic acid (single dose) on healing after arthroscopic repair of chronic rotator cuff tears.\n\nThe study including its financial support was approved by the medical director of the General Accident Insurance Institution (AUVA) , Dr. Roland Frank.\n\nHypothesis to prove: Adjuvant intravenous therapy with zoledronic acid does improve tendon healing after arthroscopic reconstruction of chronic rotator cuff tears compared to a control group without adjuvant therapy with zoledronic acid.,",[63,28],"Orthopedics",[65,66,67],"zoledronic acid","chronic rotator cuff tears","arthroscopic repair","RECRUITING","2024-03-14",{"date":71,"type":39},"2024-03-18",{"date":73,"type":39},"2022-08-22",{"date":75,"type":22},"2030-12",{"name":77,"class":46},"AUVA Traumazentrum Vienna Site UKH Meidling"]