ChiCTR2500111494 版本V1.0 版本创建时间2025/10/31 16:36:37 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500111494 

最近更新日期：

Date of Last Refreshed on：

 2025-10-31 16:36:32 

注册时间：

Date of Registration：

 2025-10-31 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

富马酸奥赛利定注射液在急诊院前严重创伤患者镇痛的应用价值研究

Public title：

Study on the application value of oxalidine fumarate injection for analgesia in emergency pre-hospital patients with severe trauma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

富马酸奥赛利定注射液在急诊院前严重创伤患者镇痛的应用价值研究

Scientific title：

Study on the application value of oxalidine fumarate injection for analgesia in emergency pre-hospital patients with severe trauma

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

李强 

研究负责人：

李强 

Applicant：

Qiang Li 

Study leader：

Qiang Li 

申请注册联系人电话：

Applicant telephone：

 +86 188 2887 7788

研究负责人电话：

Study leader's
telephone：

+86 188 2887 7788

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 xiaoqiang0403@163.com

研究负责人电子邮件：

Study leader's E-mail：

 xiaoqiang0403@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

四川省富顺县富世镇吉祥路490号

研究负责人通讯地址：

四川省富顺县富世镇吉祥路490号

Applicant address：

No. 490, Jixiang Road, Fushi Town, Fushun County, Sichuan Province

Study leader's address：

No. 490, Jixiang Road, Fushi Town, Fushun County, Sichuan Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

富顺县人民医院

Applicant's institution：

Fushun County People's Hospital

研究负责人所在单位：

富顺县人民医院

Affiliation of the Leader：

Fushun County People's Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024-021

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

富顺县人民医院伦理委员会

Name of the ethic committee：

Fushun County People's Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-07-02 00:00:00

伦理委员会联系人：

曾锐

Contact Name of the ethic committee：

Zeng Rui

伦理委员会联系地址：

四川省富顺县富世镇吉祥路490号

Contact Address of the ethic committee：

No. 490, Jixiang Road, Fushi Town, Fushun County, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 182 2773 0733

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

富顺县人民医院

Primary sponsor：

Fushun County People's Hospital

研究实施负责（组长）单位地址：

四川省富顺县富世镇吉祥路490号

Primary sponsor's address：

No. 490, Jixiang Road, Fushi Town, Fushun County, Sichuan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

富顺县人民医院

具体地址：

四川省富顺县富世镇吉祥路490号

Institution
hospital：

Fushun County People's Hospital

Address：

No. 490, Jixiang Road, Fushi Town, Fushun County, Sichuan Province

经费或物资来源：

划拨+自筹

Source(s) of funding：

Transfer + self-financing

研究疾病：

严重创伤  

Target disease：

severe trauma

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探索院前严重创伤患者镇痛治疗的新方法  

Objectives of Study：

Exploring new methods of analgesic treatment for prehospital severe trauma patients

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1、年龄>=18岁和<=75岁； 2、严重创伤患者ISS评分＞16分； 3、NRS或Wong-Baker量表疼痛评级为Ⅱ、Ⅲ级疼痛患者； 4、获取患者或家属知情同意。

Inclusion criteria

1. Age >=18 years old and <=75 years old; 2. Severe trauma patients with ISS score>16 points; 3. Patients with pain ratings of grade II or III on NRS or Wong Baker scales; 4. Obtain informed consent from patients or their families.

排除标准：

1、年龄<18岁，或年龄>75岁； 2、妊娠或哺乳； 3、使用单氧化酶抑制剂的； 4、严重的、已存在的实质性肝病伴临床显著的门静脉高压、Child-Pugh C级肝硬化或急性肝衰竭； 5、急慢性肾功能不全需要透析治疗患者； 6、严重颅脑损伤，脑肿瘤，颅内压增高，脑血管意外，昏迷，癫痫持续状态等； 7、有酒精或药物滥用史的患者； 8、任何妨碍正确评估认知功能的情况，如语言和感觉障碍或精神障碍(语言困难或精神器质性功能障碍)且无法完成Wong-Baker量表； 9、无法获得知情同意或授权； 10、筛查前1个月内参加其他探索性临床试验； 11、已知阿片类、氯胺酮药物过敏； 12、严重血流动力学不稳定，严重休克、多器官功能衰竭患者 13、重度ARDS 患者；

Exclusion criteria：

1. Age under 18 years old, or age over 75 years old; 2. Pregnancy or lactation; 3. Using single oxidase inhibitors; 4. Severe and existing substantial liver disease accompanied by clinically significant portal hypertension, Child Pugh C-grade cirrhosis, or acute liver failure; 5. Patients with acute or chronic renal insufficiency requiring dialysis treatment; 6. Severe traumatic brain injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, status epilepticus, etc; 7. Patients with a history of alcohol or drug abuse; 8. Any situation that hinders the correct assessment of cognitive function, such as language and sensory disorders or mental disorders (language difficulties or organic dysfunction) and inability to complete the Wong Baker scale; 9. Unable to obtain informed consent or authorization; 10. Participate in other exploratory clinical trials within one month prior to screening; 11. Known allergies to opioid and ketamine drugs; 12. Patients with severe hemodynamic instability, severe shock, and multiple organ failure; 13. Patients with severe ARDS;

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2026-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-12-28 00:00:00 至 To 2026-10-01 00:00:00

干预措施：

Interventions：

组别：

氯胺酮注射液组

样本量：

 40

Group：

Ketamine injection group

Sample size：

干预措施：

符合入组条件的患者入组后（氯胺酮注射液组）：完成院前急救必要评估及急救措施后，首剂氯胺酮注射液0.3mg/kg IV［７］，以0.3mg/kg /h持续静脉泵入；5分钟后使用镇痛疗效判定工具进行疼痛治疗评估 ：疼痛管理指数：疼痛处理的评估及方法的调整可根据疼痛管理指数进行动态管理。 疼痛管理指数（ｐａｉｎ ｍａｎａｇｅｍｅｎｔ ｉｎｄｅｘ，ＰＭＩ） ＝ 干预前疼痛水平－止痛后疼痛水平，其值在－ ３ ～ ＋ ３ 分，以０为界限， 负数表明疼痛干预不充分，正数表明疼痛干预有效［２９］ 。尼莫地平法：疗效指数＝（镇痛前评分－镇痛后评分）／镇痛前评分×１００％。当疗效指数≥５０％，表明镇痛效果较好，镇痛方案无需调整；当疗效指数﹤５０％，表明镇痛效果较差，［7，37］，疼痛干预无效可追加一次剂量0.3-0.5mg/kg IV，5分钟后上述方式再次评价，如镇痛效果不佳加用氯胺酮0.3mg IV加强镇痛，再次每5分钟评估镇痛效果,每次增加氯胺酮0.1mg/kg/h,直至0.5mg/kg/h，如无法完成镇痛目标，加用瑞芬太尼0.5-1.0ug/kg IV，瑞芬太尼 1.5ug/kg/h持续泵入；院前治疗方式由临床医师决定，直至完成必要的抢救措施和（或）相关检验检查，送入临床科室完成交接班。

干预措施代码：

 40

Intervention：

After patients who meet the enrollment conditions are enrolled (ketamine injection group): After completing the necessary pre-hospital first aid assessment and first aid measures, the first dose of ketamine injection is 0.3 mg/kg IV [7], followed by continuous intravenous administration of 0.3 mg/kg/h. Pump in; use the analgesic efficacy evaluation tool to evaluate pain treatment after 5 minutes: Pain Management Index: The evaluation of pain treatment and adjustment of methods can be dynamically managed according to the pain management index. Pain management index (PMI) = pain level before intervention - pain level after analgesia. The value ranges from -3 to +3 points, with 0 as the limit. Negative numbers indicate insufficient pain intervention, and positive Data show that pain intervention is effective[ 29]. Nimodipine method: efficacy index = (pre-analgesia score – post-analgesia score)/pre-analgesia score × 100%. When the efficacy index is ≥50%, it indicates that the analgesic effect is good, and the analgesic regimen does not need to be adjusted; when the efficacy index is <50%, it indicates that the analgesic effect is poor [7,37]. If the pain intervention is ineffective, an additional dose of 0.3-0.5 can be added. mg/kg IV, and re-evaluate the above method after 5 minutes. If the analgesic effect is not good, add ketamine 0.3 mg IV to strengthen the analgesia. Evaluate the analgesic effect again every 5 minutes, increasing the ketamine 0.1 mg/kg/h each time until 0.5 mg/kg/h. If the analgesic goal cannot be achieved, add remifentanil 0.5-1.0ug/kg IV and remifentanil 1.5ug/kg/h by continuous pumping; the pre-hospital treatment method is determined by the clinician. , until necessary rescue measures and/or relevant inspections are completed, and then sent to the clinical department to complete the handover.

Intervention code：

组别：

富马酸奥赛利定注射液组

样本量：

 40

Group：

Oxalidine fumarate injection group

Sample size：

干预措施：

符合入组条件的患者入组后(富马酸奥赛利定注射液组):完成院前急救必要评估及急救措施 后，首剂富马酸奥赛利定注射液1mg IV,以 6ug/kg/h 持续静脉泵入；5分钟后使用镇痛疗效判定工具进行疼痛治疗评估：疼痛管理指数：疼痛处理的评估及方法的调整可根据疼痛管理指数进行 动态管理。疼痛管理指数(pain management index,PMI)=干预前疼痛水平一止痛后疼痛水平， 其值在 一 3～+3分，以0为界限，负数表明疼痛干预不充分，正数表明疼痛干预有效[29]。 尼莫地平法：疗效指数=(镇痛前评分 一 镇痛后评分)/镇痛前评分×100%。当疗效指数≥5 0 %,表明镇痛效果较好，镇痛方案无需调整；当疗效指数<50%,表明镇痛效果较差[7,37] 疼痛干预无效可追加一次剂量1mg IV,5分钟后上述方式再次评价，如镇痛效果不佳在原剂量的基 础上增加奥赛利定2-10ug/kg/h;如无法完成镇痛目标，加用瑞芬太尼0.5-1.0ug/kg IV,瑞芬太 尼1.5ug/kg/h持续泵入，院前治疗方式由临床医师决定，直至完成必要的抢救措施和(或)相关 检验检查，送入临床科室完成交接班。

干预措施代码：

 40

Intervention：

After patients who meet the enrollment conditions are enrolled (oxalidine fumarate injection group): After completing the necessary pre-hospital first aid assessment and first aid measures, the first dose of oxalidine fumarate injection 1mg IV, at 6ug/kg/ h Continuous intravenous pumping; use the analgesic efficacy evaluation tool to evaluate pain treatment after 5 minutes: Pain Management Index: The evaluation of pain treatment and adjustment of methods can be carried out according to the pain management index Dynamic management. Pain management index (PMI) = pain level before intervention - pain level after analgesia, Its value ranges from -3 to +3 points, with 0 as the limit. Negative numbers indicate insufficient pain intervention, and positive numbers indicate effective pain intervention [29]. Nimodipine method: efficacy index = (pre-analgesia score - post-analgesia score)/pre-analgesia score × 100%. When the efficacy index ≥50%, it indicates that the analgesic effect is good, and the analgesic regimen does not need to be adjusted; when the efficacy index is <50%, it indicates that the analgesic effect is poor [7,37] If the pain intervention is ineffective, an additional dose of 1mg IV,5 Evaluate again in the above manner after 10 minutes. If the analgesic effect is not good, the original dose will be reduced. On the basis of this, add oxalidine 2-10ug/kg/h; if the analgesic goal cannot be achieved, add remifentanil 0.5-1.0ug/kg IV, and remifentanil 1.5ug/kg/h will be continuously pumped. The initial treatment method is decided by the clinician until the necessary rescue measures and/or relevant inspections are completed and the patient is sent to the clinical department to complete the handover.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 富顺县人民医院 

单位级别：

 三甲 

Institution
hospital：

Fushun County People's Hospital

Level of the institution：

Top three

测量指标：

Outcomes：

指标中文名：

目标镇痛范围内时间所占院前急救时间百分比

指标类型：

主要指标

Outcome：

Percentage of pre hospital emergency time within the target analgesia range

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

研究药物给药期间,达到目标镇痛的起效时间长短以及药物总用量

指标类型：

主要指标

Outcome：

Study the duration of onset of target analgesia during drug administration and the total dosage of the drug

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良反应发生率

指标类型：

次要指标

Outcome：

Adverse reaction incidence rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用方便抽样法选取2024年7月至2026年7月在本院急诊医学科院前收治的严重创伤患者80例，实验组和对照组各40例。符合入组标准的重症患者采用随机数字表法及随机数余数分组法进行分组，即将纳入研究的严重创伤患者进行编号，从随机数字表中任意一个数开始，沿同一方向顺序获取每个患者一个随机数字，随机数除以组数（本研究各为2组）求余数并按其分组，最后根据每个组所需的实际病例数进行调整。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study used convenience sampling to select 80 severe trauma patients admitted to the Emergency Medicine Department of our hospital from July 2024 to July 2026. There were 40 patients in the experimental group and 40 patients in the control group. Severely ill patients who meet the inclusion criteria are grouped using a random number table method and a random number remainder grouping method. The severely traumatized patients included in the study are numbered, and a random number is obtained for each patient in the same direction starting from any number in the random number table. The random number is divided by the number of groups (2 groups in this study) to obtain the remainder and grouped accordingly. Finally, adjustments are made based on the actual number of cases required for each group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

两组患者均接受院前常规监护和相应治疗方案，治疗方式由临床医师决定，试验药品对患者设盲，对医护人员不设盲。

Blinding：

Both groups of patients received routine pre hospital monitoring and corresponding treatment plans, and the treatment method was determined by the clinical physician. The experimental drug was blinded to the patients, but not to the medical staff.

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)，试验结束六个月之后上传

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

China National Centre for Bioinformatics (https://ngdc.cncb.ac.cn/gsub/), to be uploaded six months after the conclusion of the trial.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-10-31 16:36:32