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右美托咪定用于非气管插管创伤性肋骨骨折患者镇痛的随机临床试验

Dexmedetomidine for Analgesia in Nonintubated Patients With Traumatic Rib Fractures: A Randomized Clinical Trial.

作者信息

Nahmias Jeffry, Stopenski Stephen, Jebbia Mallory, Atallah Steven, Kirby Katharine A, Alvarez Claudia A, Aryan Negaar, Tay-Lasso Erika, Dolich Matthew, Lekawa Michael, Swentek Lourdes, Santos Jeffrey, Schubl Sebastian, Kuza Catherine, Nguyen Ninh, Grigorian Areg

机构信息

Department of Surgery, University of California, Irvine, Orange.

Department of Pharmacy, University of California, Irvine, Orange.

出版信息

JAMA Surg. 2025 Sep 3. doi: 10.1001/jamasurg.2025.3221.

DOI:10.1001/jamasurg.2025.3221
PMID:40900569
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12409648/
Abstract

IMPORTANCE

Traumatic rib fractures are associated with significant morbidity, including pulmonary complications and prolonged opioid use. Identifying adjunctive treatments that can reduce opioid consumption without compromising safety remains a clinical priority, particularly in nonintubated trauma patients.

OBJECTIVE

To evaluate whether adding dexmedetomidine to standard multimodal analgesia reduces opioid consumption in nonintubated patients in the intensive care unit (ICU) with traumatic rib fractures. It was hypothesized that adjunctive dexmedetomidine would reduce opioid use and improve numerical pain scores.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, randomized, double-blind, placebo-controlled clinical trial was conducted from July 2021 to October 2023. Data were analyzed during January 2024. The study took place at a single academic level I trauma center ICU. Participants included nonintubated adult trauma patients (18 years or older) with 3 or more rib fractures who were admitted to the ICU. Exclusion criteria included a Glasgow Coma Scale score less than 14, bradycardia, hypotension, pregnancy, cirrhosis, chronic opioid use, or inability to consent. Of 41 enrolled patients, 19 received dexmedetomidine (46.3%).

EXPOSURE

Continuous intravenous infusion of dexmedetomidine (0.4 to 0.6 µg/kg per hour) or placebo (normal saline) for up to 48 hours, in addition to standard multimodal pain management.

MAIN OUTCOMES AND MEASURES

The primary outcome was the numerical pain score (NPS) over 48 hours. Secondary outcomes included oral morphine equivalents (OME) at 24 and 48 hours and pulmonary complications.

RESULTS

Among 41 patients (median age, 62 years; median injury severity score, 20), no significant differences were found in baseline characteristics between groups. Mean OME at 24 hours was 59.2 mg (dexmedetomidine) vs 54.9 mg (placebo) and 125.5 mg vs 87.1 mg at 48 hours. Median NPS was 4 in both groups. Pulmonary complication rates and ICU length of stay were also similar. Dexmedetomidine was discontinued in 47.4% of patients due to adverse events or patient request.

CONCLUSIONS AND RELEVANCE

Adjunctive dexmedetomidine did not reduce opioid consumption, improve pain scores, or lower pulmonary complication rates in nonintubated patients in the ICU with traumatic rib fractures. These findings do not support routine use of dexmedetomidine for analgesia in this patient population.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05321121.

摘要

重要性

创伤性肋骨骨折会导致严重的发病率,包括肺部并发症和长期使用阿片类药物。确定能够在不影响安全性的情况下减少阿片类药物消耗的辅助治疗方法仍然是一项临床重点,尤其是在非插管创伤患者中。

目的

评估在标准多模式镇痛基础上加用右美托咪定是否能减少重症监护病房(ICU)中创伤性肋骨骨折的非插管患者的阿片类药物消耗。研究假设辅助使用右美托咪定将减少阿片类药物的使用并改善数字疼痛评分。

设计、地点和参与者:这项前瞻性、随机、双盲、安慰剂对照临床试验于2021年7月至2023年10月进行。2024年1月进行数据分析。该研究在一家一级学术创伤中心的ICU开展。参与者包括入住ICU的3根或更多肋骨骨折的非插管成年创伤患者(18岁及以上)。排除标准包括格拉斯哥昏迷量表评分低于14分、心动过缓、低血压、妊娠、肝硬化、长期使用阿片类药物或无法签署知情同意书。在41名入组患者中,19名接受了右美托咪定治疗(46.3%)。

暴露

除标准多模式疼痛管理外,持续静脉输注右美托咪定(每小时0.4至0.6 μg/kg)或安慰剂(生理盐水)长达48小时。

主要结局和测量指标

主要结局是48小时内的数字疼痛评分(NPS)。次要结局包括24小时和48小时的口服吗啡当量(OME)以及肺部并发症。

结果

在41名患者(中位年龄62岁;中位损伤严重程度评分20分)中,两组间基线特征无显著差异。24小时时的平均OME,右美托咪定组为59.2 mg,安慰剂组为54.9 mg;48小时时分别为125.5 mg和87.1 mg。两组的中位NPS均为4分。肺部并发症发生率和ICU住院时间也相似。47.4%的患者因不良事件或患者要求停用了右美托咪定。

结论及相关性

在ICU中,辅助使用右美托咪定并未减少创伤性肋骨骨折的非插管患者的阿片类药物消耗、改善疼痛评分或降低肺部并发症发生率。这些发现不支持在该患者群体中常规使用右美托咪定进行镇痛。

试验注册

ClinicalTrials.gov标识符:NCT05321121。

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本文引用的文献

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Pain management for hospitalized patients with rib fractures: A systematic review of randomized clinical trials.住院肋骨骨折患者的疼痛管理:随机临床试验的系统评价。
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Analgesic Techniques for Rib Fractures-A Comprehensive Review Article.肋骨骨折的镇痛技术——一篇综述文章
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J Trauma Acute Care Surg. 2023 Apr 1;94(4):567-572. doi: 10.1097/TA.0000000000003811. Epub 2022 Oct 25.
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Admission Triage With Pain, Inspiratory Effort, Cough Score can Predict Critical Care Utilization and Length of Stay in Isolated Chest Wall Injury.胸痛、吸气努力、咳嗽评分入院分诊可预测孤立性胸壁损伤患者的重症监护利用和住院时间。
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