Prehospital Analgesia With Intra-Nasal Ketamine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion experiencing 2-point or more pain score reduction at 30 minutes
研究概览
简要总结
Acute painful conditions make-up a large proportion of pre-hospital transports in British Columbia (BC) yet Basic Life Support (BLS) paramedics have limited options to provide analgesia and therefore adequate and timely pain relief is often significantly delayed.
Inhaled nitrous oxide is commonly used as a pre-hospital analgesic and is considered "usual care" for pre-hospital providers in BC, but its utility in severe pain is uncertain. Moreover, nitrous oxide is limited in its effectiveness by a short duration of action, nausea, vomiting, and the necessity for patient cooperation.
IN Ketamine has been shown to provide rapid, easily-administered, and well-tolerated analgesia in many settings. The investigators believe that the addition of IN ketamine to usual care with nitrous oxide inhalation for adults experiencing moderate to severe intensity acute pain in the pre-hospital setting will result in improved pain severity, improved patient-reported comfort, and improved patient satisfaction.
详细描述
Purpose:
The purpose of this study is to see whether intra-nasal (IN) Ketamine (50 mg / ml) solution (Sandoz; Drug Identification Number (DIN) 02246796) administered via mucosal atomization device (LMA MAD300 Nasal TM; Wolfe Tory Medical Inc., San Diego, CA), in addition to usual care with nitrous oxide inhalation, to pre-hospital patients being transported by British Columbia Emergency Health Services (BC EHS) Basic Life Support (BLS) paramedics with moderate to severe pain (pain > 5/10 on a validated numerical rating scale or NRS) will improve pain relative to usual care plus placebo.
Hypothesis:
It is hypothesized that the addition of IN ketamine to usual care with nitrous oxide inhalation for adults experiencing moderate to severe intensity acute pain in the pre-hospital setting will result in a greater proportion of patients experiencing a 2-point or more reduction in verbal numerical rating scale (VNRS) pain score within 30 minutes, as well as improved patient-reported comfort, reduced nitrous oxide requirements, and improved patient and provider satisfaction compared to usual care alone.
Background:
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have an acute painful condition, as determined by the Emergency Health Services attendant
- •A pain score of 5 or greater (signifying moderate or severe pain)
- •Desire for analgesia when queried.
排除标准
- •Less than 18 years of age.
- •Previous hypersensitivity, intolerance or allergy to ketamine
- •Chest pain
- •Altered mental status
- •Inability self-report pain score
- •Pregnancy
- •Nasal occlusion
- •Systolic Blood Pressure < 90 mm Hg
- •Requiring immediate attention of the paramedic
- •Ineligible to receive inhaled nitrous oxide as per BC EHS protocols
研究组 & 干预措施
Intranasal Ketamine
Ketamine dosing will be weight-based as follows: 30mg of IN ketamine for patients weighing 50 kg or less; 50 mg of IN ketamine for patients weighing 50 kg to 100 kg; and 75 mg of IN ketamine for patients weighing greater than 100 kg (i.e. 0.5 mg/kg to 1.0 mg/kg of intranasal ketamine). Syringes containing ketamine will be prepared from the intravenous formulation of Ketamine (50 mg / ml) solution (Sandoz; DIN 02246796) and stored in pre-filled 5 ml syringes. Ketamine will be administered to patients through a mucosal atomization device. One-half of the pre-specified volume will be administered into each nare. No repeat doses will be administered.
干预措施: Ketamine (Drug)
Placebo
Syringes containing normal saline will be prepared such that the volume of normal saline in 5 ml syringes matches that of the ketamine for each of the weight based groups previously specified in the Treatment Arm Description. Syringes containing normal saline will also be labeled "Study Drug". The normal saline will also be administered to patients through a mucosal atomization device. One-half of the pre-specified volume will be administered into each nare. No repeat doses of placebo will be administered.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Proportion experiencing 2-point or more pain score reduction at 30 minutes
时间窗: 30 minutes.
The proportion of patients experiencing a 2-point or more reduction in NRS pain score at 30 minutes.
次要结局
- Patient Satisfaction(At 30 minutes post analgesia administration.)
- Median Nitrous Oxide Consumption(At 30 minutes post analgesia administration.)
- Proportion experiencing 2-point or more pain score reduction at 15 minutes(15 minutes)
- The proportion of patients feeling "a lot better" or "moderately better" at 30 minutes post medication delivery or hospital at hospital arrival(30 minutes)
- Adverse Events(Every 15 minutes until care transferred to Emergency Department)
- The proportion of patients feeling "a lot better" or "moderately better" at 15 minutes.(15 minutes)
- The proportion of patients feeling "a lot better", "moderately better" or "a little better" at 15 minutes and at 30 minutes.(15 minutes, 30 minutes)
- Provider Satisfaction(At 30 minutes post analgesia administration.)
- Median reduction in pain score at 15 minutes(15 minutes)
- Median reduction in pain score at 30 minutes(30 minutes)
研究者
Gary Andolfatto
Assistant Professor, University of British Columbia Department of Emergency Medicine
University of British Columbia