2023-504847-15-00招募中3 期
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)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 915
- 试验地点
- 10
- 主要终点
- Proportion of children relieved at 30 minutes after the IN spray. The pain will be evaluated with : An hetero-evaluation by the EVENDOL Scale for children aged less than 8 years. An auto-evaluation by the Numeric Pain Rating Scale (NRS-11) for children aged 8 years to less than 18 years. Pain relief is defined as EVENDOL score ≤ 5/15 or NRS-11 score ≤ 3/10.
研究概览
简要总结
To demonstrate the superiority of a procedure consisting in IN administration of sufentanil followed by IV administration of morphine as soon as possible {IN sufentanil + IV morphine (as a standard of care) }, when compared to placebo and IV administration of morphine as soon as possible {IN Placebo + IV morphine (as a standard of care)}, on the efficacy of the analgesia at 30 minutes, in children with SCD presenting to the pediatric ED with a severe VOC.
研究设计
- 分配方式
- Randomized
- 主要目的
- Invope
- 盲法
- Double (Investigator, Subject, Analyst)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •At inclusion visit • Sickle-cell disease = Hemoglobin SS or SC or Sß-thalassemia • Age < 18 years old • Weight > 10 kgs • Registered with the social security scheme (or State Medical Aid - AME) or his/her beneficiaries • Informed consent of the holder (s) of the exercise of parental authority
- •At randomization visit • Age < 18 years old • 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. • Severe pain determined at triage, defined as: - EVENDOL ≥ 10/15 in children aged 0-18 years (this pain scale is allowed in children > 8 years only for randomization) or -NRS-11 ≥ 7/10 in children aged 8 years to less than 18 years • Informed consent of the holder (s) of the exercise of parental authority signed at inclusion visit or at randomisation visit
排除标准
- •At inclusion visit • Known cirrhosis • End-stage renal disease requiring kidney dialysis • Known hypersensitivity to sufentanil, any of the excipients or to morphine • Facial malformation, epistaxis, blocked or traumatised nose. • Patient's or parent's refusal to participate • Parents who do not speak French
- •At randomization visit • Strong opioids received <6 hours (morphine, oxycodone, hydromorphone, fentanyl, sufentanil, nalbuphine) • Respiratory failure (tachypnea; bradypnea; paradoxical breathing; grunting; head-bobbing; nasal flaring; retractions (subcostal, suprasternal, intercostal, sternal)) • Oxygen saturations below 95% on initial assessment • Hemodynamic disorders: tachycardia, hypotension • Altered conscious state as defined by a Glasgow Coma score less than 15 • Patient's or Parent's refusal to participate or withdrawal of parental consent • Patient has already been randomised to the INVOPE trial during a previous VOC • Positive urinary pregnancy test for woman of childbearing potential (postpubertal female with sexual activity), • Participation in another interventional trial
结局指标
主要结局
Proportion of children relieved at 30 minutes after the IN spray. The pain will be evaluated with : An hetero-evaluation by the EVENDOL Scale for children aged less than 8 years. An auto-evaluation by the Numeric Pain Rating Scale (NRS-11) for children aged 8 years to less than 18 years. Pain relief is defined as EVENDOL score ≤ 5/15 or NRS-11 score ≤ 3/10.
Proportion of children relieved at 30 minutes after the IN spray. The pain will be evaluated with : An hetero-evaluation by the EVENDOL Scale for children aged less than 8 years. An auto-evaluation by the Numeric Pain Rating Scale (NRS-11) for children aged 8 years to less than 18 years. Pain relief is defined as EVENDOL score ≤ 5/15 or NRS-11 score ≤ 3/10.
次要结局
- a) Proportion of children relieved (EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10) at 10, 20, 40, 50 and 60 minutes after the IN spray;
- b) Proportion of children with a moderate pain (EVENDOL ≤ 9/15 or NRS-11 ≤ 6/10) at 10, 20, 30, 40, 50 and 60 minutes after the IN spray;
- c) Time from triage to relief (EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10) Time from triage to venous access Time from triage to IV morphine initiation Proportion of children with a first dose of opioids within 30 min of arrival Time from triage to parenteral opioid initiation (IV morphine or IN Sufentanil) Time from triage to admission/discharge decision
- d) Morphine consumption (mg) 60, 120 and 240 minutes after the IN injection;
- e) Rates of hypotension, hypoxia, bradycardia, respiratory distress, headache, nausea, vomiting, sleepiness and itchiness until 4 hours after the IN injection;
- f) All adverse events;
- g) Rate of admission after the ED visit Length of hospital stay: at hospital discharge;
- h) 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
- i) Satisfaction with the quality of analgesia and management during the emergency room stay = o For children > 8 years - Total Quality Pain Management and Desire to receive the same intranasal treatment during a future severe VOC by children and parent o For children ≤ 8 years - Global satisfaction with treatment (NRS-11, by parent and patient) - Total Quality Pain Management and Desire to receive the same intranasal treatment during a future severe VOC only by parent
研究者
Camille AUPIAIS
Scientific
Assistance Publique Hopitaux De Paris
研究点 (10)
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