Evaluating the Safety, Efficacy and Opiate Sparing Effects of Low-Dose, Slow Infusion Ketamine as a Battlefield Analgesic for Acute Pain in Burn Wounds.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Trajectory of Mean Wound Care Session Pain Across Sessions
研究概览
简要总结
The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual Care-Opiate (UC-O), dose/timing as per Burn Center protocol).
详细描述
Department of Defense (DoD) and the U.S. Army Medical Research and Materiel Command (USAMRMC) are funding this RCT for the following reasons:
Primary Aims:
- To evaluate the safety and efficacy of fentanyl (usual care) + placebo versus fentanyl + ketamine (low-dose, sub-anesthetic, slow-infusion) during twice daily burn wound care across a 7-day study period and 30 day outcome period.
- To evaluate the opiate sparing effect of fentanyl (usual care) + placebo versus fentanyl + ketamine (low-dose, sub-anesthetic, slow-infusion) during the 7-day study period and 30 day outcome period.
and
Secondary Aims:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Pharmacy receives order from provider and then prepares the study drug in an unmarked, nondescript delivery system ("bag") and the study drug information is entered from the bag into the pump so that delivery that is timed and volume controlled per study protocol. This is hung next to patient, connected and started. Masked personnel include provider (order study drug protocol), nurse (wound care), data assessor (Research Assistant), and consenting participant (patient with acute burn).
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40% TBSA
- •English speaking
- •pain in emergency room during initial wound evaluation (on admission) greater than 5 /10
- •estimated length of stay greater than or equal to 5 days
排除标准
- •requiring endotracheal intubation and sedation,
- •severe hearing impairment,
- •cognitive impairment status - Mini-Mental State Examination (MMSE) </=20,
- •diminished capacity unable to provide informed consent;
- •Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)
- •Safety: contraindication (e.g., potential drug interactions or medical comorbidities)
研究组 & 干预措施
Fentanyl Plus Ketamine
Study drug group
- Ketamine Loading Dose (Low Dose, Slow Infusion) =
• 0.3 mg/kg; Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, ... Then, 2. Fentanyl Loading Dose (UC, injection) =
• 1 mcg / kg. This is given to participants in both Group 1 and Group 2 initiated < 1 minute prior to wound care. 3. Ketamine (Study Drug, Infusion) = • 2.5 mcg/kg/min, Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.
Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication.
干预措施: ketamine (Drug)
Fentanyl Plus Ketamine
Study drug group
- Ketamine Loading Dose (Low Dose, Slow Infusion) =
• 0.3 mg/kg; Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, ... Then, 2. Fentanyl Loading Dose (UC, injection) =
• 1 mcg / kg. This is given to participants in both Group 1 and Group 2 initiated < 1 minute prior to wound care. 3. Ketamine (Study Drug, Infusion) = • 2.5 mcg/kg/min, Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.
Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication.
干预措施: Fentanyl (Drug)
Fentanyl Plus Saline
Usual care group
- Saline Loading Dose (Low Dose, Slow Infusion) =
• An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), ... Then, ... 2. Fentanyl Loading Dose (UC, injection) =
• 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated <1 minute prior to wound care. 3. Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.
FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Trajectory of Mean Wound Care Session Pain Across Sessions
时间窗: 7-Days across sessions
Trajectory of average pain across 7 day study protocol
Trajectory of Mean Wound Care Session Pain Within Sessions
时间窗: 7-days, within session
Trajectory of average pain within session
Mean Wound Care Pain
时间窗: Up to 40 days
Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.
Opiate Sparing Effect
时间窗: 37 days
Pro Re Nata (PRN) pain management or adjunct expressed in opiate equivalents (e.g., anxiolytic) or premed (e.g., non-protocol medications for pain, anxiety, etc); post-session (1 and 6 hours post session , e.g., pain, anxiolytic, etc).
次要结局
- Post Traumatic Stress Disorder (PTSD) Symptoms as Assessed by Davidson Trauma Scale(37 days)
- Depression Symptoms as Assessed by the Patient Health Questionnaire(37 days)