"THINK Trial: Treatment of Headache With IntraNasal Ketamine: A Randomized Controlled Trial Evaluating the Efficacy of Intranasal Ketamine Versus Standard Therapy in the Management of Primary Headache Syndromes in the Emergency Department"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- VAS 30 min
研究概览
简要总结
This is a randomized, single-blind, placebo controlled trial to evaluate the efficacy of sub-dissociative dose ketamine versus standard care therapy for acute headache management of in patients presenting to the emergency department with headache as the chief compliant.
详细描述
This is a randomized, single-blind, placebo controlled trial to evaluate the efficacy of sub-dissociative dose ketamine versus standard care therapy for acute headache management of in patients presenting to the emergency department with headache as the chief compliant. Standard care will include 25 mg of diphenhydramine (DIP) IV, 10 mg of metoclopramide (MET) IV, +/- 15-30 mg ketorolac and +/- 10 mg of dexamethasone (DEX) IV the discretion of the treating provider. This study has been approved by Brooke Army Medical Center (BAMC) institutional review board and clinicaltrials.gov registration is pending.
A convenience sample of patients 18 to 65 years of age with a chief complaint of headache will be considered for enrollment. Potential subjects are those presenting to the SAMMC ED with a chief complaint of headache. Attempts to engage subjects earlier in their ED Course (EDC) will be made. This will mitigate interruptions in the subject's EDC, possible withdrawals from the control group, and lack of subject interest in the study. The triage nurse will inform the PI or AI of any patient presenting to the ED with a chief complaint of headache. Patients meeting inclusion criteria will be provided with a brochure briefing them on the study. If they are willing to participate, then a member of the research team will obtain written consent.
Patient screening, enrollment, patient consents, and data collection will be performed by the PI or AI. Each AI will complete training regarding study details, inclusion/exclusion criteria, atomization, intranasal delivery, and ketamine pharmacokinetics which will be conducted by the PI.
Once a patient is consented the team member will obtain a study packet, and the patient will be assigned a study identification number. The study packet will contain the required forms, surveys, Wand documentation forms. The study personnel will then write on the patient's standard order sheet "SDDK Protocol, Patent #__, __kg"
All females of child-bearing age that have not had a hysterectomy or tubal ligation will receive a pregnancy test. This is a standard test performed in the ED and considered part of routine practice. A pregnancy test in females is one test that is required by all patients undergoing this clearance among other labs not applicable to this study.
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 (Participant)
盲法说明
Placebo controlled
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chief compliant of a benign, non-life threatening headache that the PI/AI believe will require parental analgesia for management.
- •Ability to comprehend, speak, read, and write in the English language
排除标准
- •Age less than 18 and greater than 65
- •History of hypersensitivity to Ketamine, diphenhydramine, metoclopramide, ketorolac or dexamethasone
- •Weight less than 45 kg or more than 115 kg
- •Pregnancy or lactating female.
- •Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis
- •Altered mental, diminished decision making capacity
- •Poor vital sign stability Hypoxia: O2 < 92%, Hypotension: SBP< 80 Hypertension: SBP>220 Heart rate: < 50 or >150 Respiratory Rate: <8 or >30
- •Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
- •Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
- •History of schizophrenia, psychosis or hallucinations (as assessed by electronic chart review)
- •History of alcohol or drug abuse
- •History of intracranial hypertension
- •History of glaucoma
- •History of HIV or immunosuppression
- •Presence of intracranial mass or vascular lesion (defined as inclusion criteria
- •As benign headaches)
- •Poorly controlled thyroid disease
- •Concomitant infections
- •History of pheochromocytoma
- •History of epilepsy
- •History of active bleeding or those receiving anticoagulants.
研究组 & 干预措施
Intranasal Ketamine arm
Intranasal ketamine administered to participant
干预措施: Ketamine (Drug)
Intranasal Ketamine arm
Intranasal ketamine administered to participant
干预措施: Normal saline (Drug)
Standard Therapy
Reglan 10 mg; Benadryl 25 mg administered to all participants Toradol 15-30 mg; dexamethasone 10 mg added at treating providers discretion.
干预措施: Metoclopramide (Drug)
Standard Therapy
Reglan 10 mg; Benadryl 25 mg administered to all participants Toradol 15-30 mg; dexamethasone 10 mg added at treating providers discretion.
干预措施: Ketorolac (Drug)
Standard Therapy
Reglan 10 mg; Benadryl 25 mg administered to all participants Toradol 15-30 mg; dexamethasone 10 mg added at treating providers discretion.
干预措施: Dexamethasone (Drug)
Standard Therapy
Reglan 10 mg; Benadryl 25 mg administered to all participants Toradol 15-30 mg; dexamethasone 10 mg added at treating providers discretion.
干预措施: Benadryl (Drug)
结局指标
主要结局
VAS 30 min
时间窗: 30 min
Change in Visual Analogue Score at 30 minutes
次要结局
- VAS 60 min(60 min)
- NRS at discharge(Discharge)
- NRS 24 hours(24 hours)
- Side effects(At 15 min then at 30 min intervals while in the ED)
- Repeat ED/primary care encounters(24 and 72 hours)
- NRS 72 Hours(72 Hours)
研究者
Danny Villalobos
Nellis AFB Deputy Flight Commander
Brooke Army Medical Center