Pilot Study: Ketamine for Acute Pain After Rattlesnake Envenomation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Pain Assessment Post Medication
研究概览
简要总结
This is a pilot study to evaluate pain responses from two different approved medications (ketamine and fentanyl) in the treatment of pain after rattlesnake envenomation (RSE). Both medications are currently used in standard practice to treat both acute and chronic pain and are options for pain management after RSE. Multiple studies exist showing ketamine to be both safe and effective for the treatment of acute pain, and to be as good as or better than opioids for this indication. The specific comparison of ketamine to fentanyl, however, has never been studied for the treatment of acute pain after rattlesnake envenomation in the United States. The investigators plan to measure pain scores after a single dose of ketamine or fentanyl in patients shortly after being envenomated, followed by continued treatment of pain guided by the treating doctor. There will be no restrictions on additional pain medications given and no other changes to the treatment of these patients during their hospitalization. This research is important because pain after RSE can be difficult to control and may require frequent, high doses of opioids for several days. An effective non-opioid medication would be helpful both to better-control pain and to reduce exposure to opioids in this patient population. This study will compare patient-reported pain scores after receiving a single dose of ketamine or fentanyl in patients with rattlesnake bites who have been admitted to the toxicology service at Banner - University Medical Center Phoenix (BUMCP).
详细描述
Multiple studies have shown ketamine to be safe and effective agent for acute pain syndromes. RSEs classically result in severe pain that can be difficult to control, despite use of opioids, non-opioid analgesics, and positioning techniques, including splinting and elevation. Furthermore, the ongoing opioid epidemic pushes clinicians to explore non-opioid agents to avoid unnecessary exposure of patients to these high-risk medications. At least one small study has shown ketamine to be safe in rattlesnake envenomated patients.
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
The blinding of the subjects is done by the investigators which is the block randomization; each block will alternate between each drug ketamine or fentanyl. Subject will not be told which pain medication they will receive.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages ≥ 18 years.
- •Able to speak and understand English.
- •RSE requiring IV pain medication for NRS pain score >
- •No allergy to ketamine or fentanyl.
- •Ability to provide informed consent.
- •≤ 24 hours from envenomation.
排除标准
- •Pregnant or lactating.
- •Prisoners.
- •Refugees.
- •History of schizophrenia.
- •Clinically intoxicated.
- •On buprenorphine therapy.
- •History of uncontrolled hypertension
- •Increased intracranial pressure
- •Systemic envenomation
研究组 & 干预措施
Fentanyl
Drug administration: A single dose of fentanyl 1mcg/kg IV, maximum 100 mcg, over 15 minutes.
Time drug given will be documented Data obtained prior to med administration and then following medication administration at intervals of 15, 30, 60 and 120 minutes
- Record vital signs (HR, B/P, resp rate, O2 sat)
- Obtain and assess pain response scores
- Pain Numerical Rating Score (NRS - 0-10)
- Richmond Agitation Sedation Scale (RASS)
- Side Effect Rating Scale for Dissociative Anesthesia (SERSDA)
- Record any airway interventions required? If yes what? new supplemental O2/BVM/intubation, jaw thrust
- Record any rescue meds, dose and time (Rescue medication - Fentanyl):
- 1 mcg/kg IV fentanyl (0.5 mcg/kg if age >55 yrs)
- Defined as rescue if given <30 min post study intervention for pain score >5 or patient requesting additional medication.
- Patient pain satisfaction score at discharge
干预措施: Fentanyl (Drug)
Ketamine
Drug administration: A single dose of ketamine 0.3 mg/kg IV over 15 minutes. Time drug given will be documented Data obtained prior to med administration and then following medication administration at intervals of 15, 30, 60 and 120 minutes
- Record vital signs (HR, B/P, resp rate, O2 sat)
- Obtain and assess pain response scores
- Pain Numerical Rating Score (NRS - 0-10)
- Richmond Agitation Sedation Scale (RASS)
- Side Effect Rating Scale for Dissociative Anesthesia (SERSDA)
- Record any airway interventions required? If yes what? new supplemental O2/BVM/intubation, jaw thrust
- Record any rescue meds, dose and time (Rescue medication - Fentanyl):
- 1 mcg/kg IV fentanyl (0.5 mcg/kg if age >55 yrs)
- Defined as rescue if given <30 min post study intervention for pain score >5 or patient requesting additional medication.
- Patient pain satisfaction score at discharge
干预措施: Ketamine (Drug)
结局指标
主要结局
Change in Pain Assessment Post Medication
时间窗: 30-120 minutes after drug administration
Pain will be assessed using a numerical rating scale (0-10, with 0 being no pain and 10 being the worst pain) at 30, 60, and 120 minutes after medication administration.
次要结局
- Adverse Events(During hospitalization, up to 120 minutes)
研究者
Meghan Spyres
Associate Professor, Emergency Medicine
University of Arizona