An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin and Nurtec (Rimegepant) in Adult Patients Presenting to the ED With Acute Headache: Prospective, Randomized, Open-Label, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Pain Score at 60 Minutes
研究概览
简要总结
Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache. Most headaches managed in the ED are benign, with 90% of these headaches classified as tension, migraine, or cluster. At present, the satisfaction with ED treatment of headache is low, and despite the multitude of available medications, the evidence- based treatment options are often quite limited. There are over twenty different types of medications available to the ED clinicians for managing headache, many with different routes of administration (parenteral, intranasal, subcutaneous, and oral). Many of these medications are provided in so-called "headache cocktail", which varies based on the physician, institution, and patient preferences.
详细描述
STUDY OBJECTIVES: To compare analgesic efficacy and rates of side effects of a proprietary formulation of orally administered aspirin and ketamine (AOK) to a Nurtec ODT (Rimegepant) for pain management in adult ED patients presenting to the ED with acute headache.
HYPOTHESIS: We hypothesize that the administration of AOK will provide similar analgesia at 60 minutes post-administration in comparison to Nurtec (Rimegepant) in adult patients presenting to the ED with acute headache. The primary outcome of this trial is the difference in participant's pain scores at 60 minutes post-medication administration.
STUDY DESIGN:
Subjects:
Patients 18 years of age and older presenting to the ED with acute headache (defined as HA lasting no more than 1 week) and an initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale and requiring oral analgesia as determined by the treating attending physician. Patients' screening and enrollment will be performed by study investigators and research assistants. All patients will be enrolled at various times of the day when study investigators will be available for patient enrollment and an ED pharmacist will be available for medication preparation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 and older
- •Acute Headache
- •Initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
- •Awake, alert, and oriented to person, place, and time
排除标准
- •altered mental status,
- •allergy to aspirin, ketamine and rimegepant,
- •pregnancy and breastfeeding
- •unstable vital signs (systolic blood pressure <90 or>180 mm Hg, pulse rate <50 or >150 beats/ min, and respiration rate <10 or >30 breaths/min)
- •inability to provide consent
- •consumption of Aspirin or NSAID's within 6 hours of arrival to the ED or acetaminophen within 4 hours of arrival
- •active PUD
- •history of GI Hemorrhage
- •history of renal and hepatic insufficiency
- •past medical history of alcohol or drug abuse
- •schizophrenia
- •clinical findings concerning for acute intracranial process, acute infections process
研究组 & 干预措施
AOK Group
Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin
干预措施: aspirin and ketamine (Drug)
Nurtec (Rimegepant) Group
Drug: 75 mg of ODT
干预措施: Nurtec (Rimegepant) (Drug)
结局指标
主要结局
Change in Pain Score at 60 Minutes
时间窗: 60 minutes
Change of pain scores on numeric rating pain scale (NRS) at 60 minutes mark form the baseline. The NRS is an 11 item Likert Scale ranging from 0 (no pain) to 10 (very severe pain) with 5 indicating moderate pain.
次要结局
未报告次要终点
研究者
Antonios Likourezos
Research Administration Director
Maimonides Medical Center