A Pilot Study of the Use of Oral Ketamine for Treatment of Vaso-Occlusive Pain in Adolescents and Young Adults
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in pain intensity scores using the Visual Analogue Scale (VAS) Pain Score Scale
研究概览
简要总结
The purpose of this study is to learn more about the feasibility of oral ketamine for the treatment of painful sickle-cell crises in children and adolescents as a supplement to intravenous (IV) opioids. There is a need for improved non-opioid analgesia for patients experiencing sickle-cell crises in the hospital and prehospital setting, as children and adolescents with sickle cell disease who experience sickle-cell crises often have severe pain that is not well controlled by high dose opioids, leading to poor pain management and opioid-related side effects.
The study will begin when patients are admitted to the Emergency Department of Boston Children's Hospital for treatment of a sickle-cell crisis. Oral ketamine will be administered every 8 hours for the next 48 hours. Patients will have continuous cardiorespiratory monitoring for the duration of the study, as per routine care, as well as monitoring by the hospital's Acute Pain Service at least twice daily for pain management and side effects of pain treatment.
At the end of the 48-hour study duration, patients will discuss with the Pain Service and Hematology Service whether to continue oral ketamine, change to intravenous ketamine, or discontinue ketamine based on clinical indications such as level of pain and sedation while on opioids.
详细描述
This is a pilot study of the feasibility of oral ketamine dosing initiated in the Emergency Department and continued for 48 hours for adolescents and young adults hospitalized with VOCs. A total of 10 patients between the ages of 12 and 24 years will receive oral ketamine 0.5 mg/kg Q8hrs for 48 hours.
Pain scores using VAS and Modified Ramsey Sedation Scores will be obtained every 4 hours per routine nursing care. Vital signs (temperature, heart rate, blood pressure, and respiratory rate) will also be taken every 4 hours throughout the study duration. Side effects (such as dysphoria, dizziness, unpleasant dreams, hallucinations, headache, and nausea) will be monitored throughout the study duration. The Acute Pain Service will assess each patient at least twice daily for pain management and side effects to pain treatment. Ketamine will be discontinued for patients who experience side effects. Patients who experience continued high pain scores will have the option of having oral ketamine discontinued and IV ketamine infusion initiated.
At the end of the 48 hour study period, patient, parent, Pain Service and Hematology Service will discuss whether to continue oral ketamine, change to intravenous ketamine, or discontinue ketamine based on clinical indications such as level of pain and sedation while on opioids. Patients and parents (for patients > 18 years) will be asked to complete a brief satisfaction survey at the end of the 48 hour study period.
Patients who are 12-24 years of age who require admission for vaso-occlusive pain will be included. Patients who do not wish to participate or who have had side effects to previous use of intravenous ketamine for treatment of vaso-occlusive pain that would preclude using ketamine for future pain episodes will not be included in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 12-24 years of age who require admission for vaso-occlusive pain
排除标准
- •Patients who have had side effects to previous use of intravenous ketamine for treatment of vaso-occlusive pain that would preclude using ketamine for future pain episodes.
- •Patient refusal to participate
研究组 & 干预措施
Ketamine
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
Change in pain intensity scores using the Visual Analogue Scale (VAS) Pain Score Scale
时间窗: Baseline, and then every 4 hours for 48 hours
The Visual Analog Scale (VAS) will be used to measure pain. Scores are recorded on a line that represents a continuum between "no pain" and "worst pain."
次要结局
- Change in Sedation Scores using modified Ramsey Sedation Scores Scale(Baseline, and then every 4 hours for 48 hours)
- Number of patients with abnormal vital signs(Baseline, and then every 4 hours for 48 hours)
- Frequency of side effects(Baseline, and then every 4 hours for 48 hours)
研究者
Christine Greco
Chief, Division of Pain Medicine
Boston Children's Hospital