Low Dose Ketamine for Blunt Thoracic Trauma: A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Milligrams of Morphine Equivalents (MME) Administered
研究概览
简要总结
The goal of this Randomized controlled double-blinded trial is to compare the addition of a ketamine infusion to placebo, when added to standard care in adult blunt trauma patients with multiple rib fractures. The main question it aims to answer are: • addition of low dose ketamine infusion (LDKI) decreases narcotic use • does LDKI impact pulmonary complications, readmission, or hospital length of stay Participants will receive usual standard of care with up to 48 hours of LDKI or placebo. If there is a comparison group: Researchers will compare infusion of a saline infusion to LDKI to see if LDKI decreases need for narcotic analgesics use.
详细描述
Study Design: Randomized controlled double-blinded trial: Patients will then be randomized into one of two study groups. Both groups will receive a normal saline infusion for 48 hours of therapy. The treatment group will have ketamine added to their saline infusion via blinded pharmacy protocol to receive continuous infusion of ketamine at 0.1mg/kg/hour. The control group will receive only normal saline. Administration will occur via piggyback infusion in accordance with nursing policy.
Setting/Participants:
- North Memorial Health Hospital: patients on 5-South - Trauma Neuro Intensive Care Unit (TNICU) and 6-West - Trauma Floor
- 50 people will take part in this study. 25 study subjects will receive an infusion of ketamine and 25 will receive a saline infusion.
- Patients 18 years of age or older with 3 or more rib fractures admitted to North Memorial Health Hospital will be considered for the study.
Study Interventions and Measures:
- Ketamine low-dose infusion administered at 0.1 mg/kg/hr for 48 hours as an adjunct to standardized rib fracture management interventions as outlined in facility-approved Guidelines for Rib Fracture Management.
- The primary study outcome will be amount of narcotic used over the 48-hour study period (expressed as morphine mg equivalents).
- Secondary outcome measures will include: need for endotracheal intubation or non-invasive positive pressure ventilation, oxygen requirements, daily incentive spirometer values, daily forced vital capacity measurements, and subjective patient pain ratings.
- Other outcomes measured will be Intensive Care Unit stay, total hospital length of stay, and adverse medication effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Pharmacist prepares medications for patients. Medication or placebo appear identical and are released to bedside nurse with weight based infusion instructions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 18 years of age or older
- •Diagnosis of 3 or more acute rib fractures related to blunt traumatic chest injury.
- •Able to undergo consent procedure and give valid consent, or availability of family member to provide consent for the study
排除标准
- •Age <18 years
- •Cognitively impaired
- •Pregnant or lactating females.
- •Glasgow Coma Score (GCS) of ≤ 14 at time of admission
- •Evidence of increased intraocular pressure
- •Presence of acute coronary syndrome
- •Diagnosed moderate to severe traumatic brain injury
- •Evidence of uncontrolled intracranial hypertension
- •History of seizures or stroke
- •History of severe psychiatric disorders
- •Allergy to ketamine
- •Currently being treated, prior to admission, with opiate agonist/antagonist therapy
- •Presence of poorly controlled hypertension, cardiac arrhythmias, and/or tachycardia on admission
- •Subjects who, in the opinion of the Investigator, may be inappropriate for study participation.
研究组 & 干预措施
Placebo/Control
Pharmacist will check randomization schedule. For placebo/control subject they will prepare an infusion bag of saline with no added medication. The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient (Pt) Name, Pt Medical record number (MR#), Pt Date of birth (DOB), and INFUSION RATE.
干预措施: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution (Drug)
Low Dose Ketamine Infusion (LDKI)
Infusion Bag will receive 100 mg of ketamine (Ketamine Infusion Subject). The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient Name, Pt MR#, Pt DOB, and INFUSION RATE. (Note: infusion rate is 0.1 mg/kg/hr and concentration of standard ketamine infusion bag is 1 mg/mL. That is, 100 mg of ketamine added to 100 mL saline).
干预措施: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution (Drug)
结局指标
主要结局
Milligrams of Morphine Equivalents (MME) Administered
时间窗: Outcome was evaluated up to a total of 96 hours (from time zero to 48 hours of infusion and up to 48 hrs after infusion stopped.
Standardized method of reporting narcotic analgesic administration by converting opioid narcotics to the equivalent dosage of morphine that would yield same result.
次要结局
- Pulmonary Complications(Up to 30 days after intervention (administration of study drug))
- ICU Admission or Hospital Readmission(Up to 30 days after intervention (administration of study drug))
研究者
Michaela A West
Trauma Research Chair
North Memorial Health Care