Intranasal Sufentanil vs oral/IV opioid for severe traumatic pain dataset

Study Design. A prospective open label study of approximatively one hundred seventy two patients admitted to the ED for severe traumatic pain and needing opioid treatment. Patients will be included only if presenting with a VAS of 7 or above. All patients will receive a standardized backbone level-1 treatment with oral or intravenous acetaminophen and non-steroidal anti-inflammatory drugs according to the local pain protocol. Patient allergies, chronic illnesses and previous conditions will be taken into account to decide the optimal level-1 analgesia. Patients will be randomized, before receiving any pain medication, to receive intranasal sufentanil (intervention) or opioids (control) according to standard local protocol (oral oxycodone or intravenous morphine according to physician judgment). At 15 to 20 minutes patients will be re-assessed, their VAS will be revaluated and, if needed, supplemental analgesia will be offered to the patient. Patient will be followed for one hour or until patient discharge, whichever comes first. Study population and selection criteria. All aspects of the study and waiver of a consent form will be approved by our Ethical Board prior to implementation. The study will be registered in Clinical trials before enrolling the first patient. All patients with post-traumatic pain in the limbs the spine or the chest, after application of the inclusion and exclusion criteria, with an indication to receive opioids, given a VAS score of 7 or above, will be included in the study. Included participants that will be admitted to CHU Saint Pierre will be retained in the study and care data will be collected according our protocol. Inclusion criteria will be a traumatic limb, chest or spine injury in a subject aged between 18 to 99 years old with an indication to receive opioid treatment. Subjects will be excluded from the study if younger than 18 years old, if pregnant or if prisoners at study inclusion. Patient with a history of chronic or acute opiate drug use, intake any opiate less than 8 hours before admission, alcohol intoxication, allergy or intolerance to opiates, renal or hepatic insufficiency, a body weight of less than 50kg, hypoxia (defined as pulse oxygen saturation below 94%) and hemodynamic instability defined as systolic blood pressure below 90mmHg and/or heart rate below 60 bpm will not be included in the study. Patients presenting with associated lesions or pain in the head, face or abdomen will also be excluded from the study. Recruitment methods. All subjects presenting to the ED during the study period for a traumatic injury of the limbs, thorax or spine requiring opioid treatment because of a VAS of 7 or above will be screened for eligibility. Data collection and reporting. Data will be collected mainly through a predetermined data collection sheet at the bedside. In some cases the patient hospital and record might be consulted for missing data. Expected outcomes. It is the sponsor’s expectation that treatment with intranasal sufentanil will be associated with a faster and larger reduction in the VAS compared to treatment with intravenous and oral opioids fifteen to twenty minutes after randomization. Moreover, the sponsor expectation is that treatment with intranasal sufentanil will be associated with larger reduction in VAS compared to treatment with intravenous and oral opioids one hour after randomization. Finally the sponsor expect that intranasal sufentanil will be associated with fewer intravenous catheter placement. Adverse reactions. Intranasal sufentanil as well as intravenous and oral opioids might be associated with numerous side effects. Nausea, vomiting, diaphoresis, dizziness, bradypnea, low oxygen saturation, bradycardia, hypotension are among the most frequently observed side effects that will be monitored during the study period and observation. We expect a similar proportion of side effects in the two groups.研究设计：本研究为一项前瞻性开放标签研究，纳入约172名因重度创伤性疼痛就诊于急诊室（Emergency Department，ED）且需阿片类药物治疗的患者。仅纳入视觉模拟评分法（Visual Analogue Scale，VAS）评分≥7分的受试者。所有患者均将按照当地疼痛诊疗规范接受标准化一级基础镇痛治疗，给予口服或静脉用对乙酰氨基酚及非甾体抗炎药（non-steroidal anti-inflammatory drugs，NSAIDs）。将结合患者的过敏史、慢性疾病及既往病史，确定最优的一级镇痛方案。在给予任何镇痛药物前，将患者随机分为两组：干预组接受鼻内舒芬太尼治疗，对照组按照当地标准诊疗规范接受阿片类药物治疗（由医师判断给予口服羟考酮或静脉吗啡）。于给药后15至20分钟对患者进行再次评估，重新测量VAS评分，必要时为患者提供追加镇痛治疗。将对患者进行为期1小时的随访，或随访至患者出院，以先发生者为准。 研究人群与入选排除标准：本研究的所有流程及豁免知情同意书的申请均将在实施前获得本院伦理委员会批准。本研究将在纳入首名患者前于临床试验注册平台完成注册。所有符合入选排除标准的四肢、脊柱或胸部创伤后疼痛，且VAS评分≥7分、需接受阿片类药物治疗的患者，将被纳入本研究。在圣皮埃尔大学附属医院（CHU Saint Pierre）收治的入组参与者将被保留在研究中，且将按照本研究方案收集其诊疗相关数据。 入选标准：年龄18至99岁，因四肢、胸部或脊柱创伤需接受阿片类药物治疗的受试者。 排除标准：年龄<18岁、妊娠、研究入组时为在押人员；有慢性或急性阿片类药物使用史、入院前8小时内使用过阿片类药物、酒精中毒、对阿片类药物过敏或不耐受、肝肾功能不全、体重<50kg、低氧血症（定义为脉搏血氧饱和度<94%）、血流动力学不稳定（定义为收缩压<90mmHg和/或心率<60次/分）；存在头部、面部或腹部相关损伤或疼痛的患者也将被排除。 招募方法：在研究周期内，所有因四肢、胸部或脊柱创伤就诊于急诊室，且因VAS评分≥7分需接受阿片类药物治疗的受试者，均将接受入组资格筛查。 数据收集与报告：数据主要通过床旁预设的数据采集表进行收集。在某些情况下，可查阅患者的住院病历以补充缺失的数据。 预期结局：本研究主办方预期，与静脉及口服阿片类药物治疗相比，鼻内舒芬太尼治疗将在随机分组后15至20分钟带来更快、更显著的VAS评分下降。此外，主办方预期在随机分组后1小时，鼻内舒芬太尼治疗组的VAS评分下降幅度将大于静脉及口服阿片类药物治疗组。最后，主办方预期鼻内舒芬太尼治疗将减少静脉导管的置入需求。 不良反应：鼻内舒芬太尼以及静脉、口服阿片类药物均可能引发多种不良反应。恶心、呕吐、出汗、头晕、呼吸减慢、低氧饱和度、心动过缓、低血压是研究期间及观察阶段将被监测的最常见不良反应。我们预期两组的不良反应发生率相似。