RELIEF-RC: Relief Efficacy of LIdocaine Versus morphinE For Acute Renal Colic in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Response to treatment
研究概览
简要总结
The opioid epidemic continues to be a major public health crisis in the United States. According to the Center for Disease Control, approximately 8 million Americans reported misusing prescription opioids in 2023, with over 5 million Americans reporting that they suffer from opioid use disorder. The United States government estimates that 105,000 people died from drug overdose in 2023, and approximately 80,000 of those deaths can be attributed to opioids (~76%). In acknowledgement of the opioid crisis, we wish to contribute to ongoing efforts to reduce unnecessary and excessive opioid prescription.
In 2012, researchers in Iran published a randomized controlled trial comparing intravenous (IV) lidocaine to IV morphine for acute renal colic, reporting that 90% patients responded "successfully" in the lidocaine group versus 70% in the morphine group. They also concluded that there was a statistically significant difference between pain scores between the two groups at all time points, favoring the lidocaine group. However, the study was conducted at a single emergency department in Tabriz, Iran, with a relatively homogenous patient population, and the researchers did not explicitly define their primary outcome variable for what constituted a "successful" response in the treatment groups. The investigators of this study aim to build upon this preliminary evidence by recruiting a more diverse population to improve generalizability and by predefining pain-reduction thresholds to allow for more meaningful comparison between the interventions.
详细描述
Purpose
● To determine whether IV lidocaine is more efficacious than IV morphine in decreasing or resolving acute renal colic pain refractory to initial treatment with parenteral ketorolac
Primary Objective ● To compare the efficacy of IV lidocaine versus IV morphine in achieving at least 50% reduction of pain score at 30 minutes for renal colic requiring rescue medication after initial treatment with parenteral ketorolac
Secondary Objectives
- To compare reduction in pain scores at 15, 60, and 90 minutes between the two intervention groups;
- To determine if there is a statistically significant difference in emergency department length of stay (ED LOS) between the two intervention groups
- To determine if there is a statistically significant difference in need for further rescue medications between the two intervention groups
- To determine the incidence of adverse effects between the two intervention groups
- To evaluate whether there is a correlation between age and efficacy of treatment between the two intervention groups
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
- Single (Outcomes Assessor)
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
- •In order to be eligible for inclusion in the study, an individual must meet all of the following criteria:
- •Age ≥ 18 years at time of visit
- •Able and willing to consent for participation in study
- •Documentation of suspected renal colic as primary complaint as evidenced by reported flank pain, back pain, abdominal pain, or groin pain, or as determined by the treating clinician
- •Requires additional treatment due to inadequate analgesia or clinical suspicion of unsafe discharge secondary to pain after initial treatment with parenteral ketorolac
排除标准
- •Any individual who meets any of the following criteria will be excluded from participation in this study:
- •Age < 18 years
- •Use of analgesia for renal colic within 6 hours prior to clinician evaluation
- •Inability or unwillingness to consent for participation in study
- •Experienced a severe adverse event that required clinician intervention after initial treatment with parenteral ketorolac
- •Documented history of allergic or anaphylactic reaction to NSAIDs, lidocaine, or morphine
- •Documented history of cardiac arrhythmias
- •Documented history of chronic use of opioid medications for unrelated diagnoses
- •Currently pregnant
- •Documented history of end-stage renal or hepatic dysfunction
- •Clinical contraindications to NSAIDs, lidocaine, or morphine per clinician discretion
研究组 & 干预措施
Lidocaine Drip
Weight-based dose of IV lidocaine will be 1.5 mg/kg, maximum 200 mg, delivered as IV infusion over 10 minutes
干预措施: Lidocaine (Drug)
Morphine, IV Push
Weight-based IV morphine will be 0.1 mg/kg, maximum 10 mg, delivered as IV push.
干预措施: Morphine 0,1 mg/kg (Drug)
结局指标
主要结局
Response to treatment
时间窗: 30 minutes after completion of medication administration
Pain assessment using a numeric rating scale (0 to 10) at 30 minutes
次要结局
- Emergency Department Length of Stay(From time of patient registration in the emergency department to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours)
- Response to treatment(15, 60, 90 minutes after completion of medication administration)
- Adverse events(From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours)
- Rescue medications(From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours)
研究者
Sarah Aly
Assistant Professor of Emergency Medicine
Loma Linda University