Pre-hospital Care With Intra-Nasal Ketamine for Transport (PRECINKT): A Pilot Study
Condition: Pain; Traumatic Limb Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators hypothesize that intra-nasal ketamine, for analgesia of patients with
      moderate to severe pain in an alpine setting, will provide a clinically significant reduction
      in pain and provide an effective and feasible alternative to intravenous opioids.

      The investigators wish to know:

        1. Is our study protocol feasible to study INK in a mountain, prehospital care environment?

        2. What estimate can be made of recruitment rates?

        3. Does studying the use of INK interfere with or delay care at Whistler/Blackcomb?

        4. Is intra-nasal ketamine an effective and safe method for controlling pain in our study
           population and setting?

        5. Does intranasal ketamine provide a clinically significant reduction in pain or do
           patients require additional IV narcotics for extraction?

        6. Are there any significant changes in vital signs after administration of intra-nasal
           ketamine

        7. Does the use of intra-nasal ketamine reduce time of patient extraction and transport in
           the alpine pre-hospital setting?

        8. Are there any long term sequelae of INK at one week?
    

Detailed description: 
      Whistler/Blackcomb is a large world-class resort that attracts hundreds of thousands of
      skiers and snowboarders annually for it's steep terrain and excellent on-mountain facilities.
      Ski patrol operations exist on both mountains and respond to over 10000 injuries per year
      (1). As both skiing and snowboarding activities gain popularity, the number of people injured
      also rises (2) as does the demand on ski patrol and attending on-mountain physicians to
      provide adequate on-mountain treatment.

      The provision of analgesia, both to relieve patient suffering and facilitate transport, is a
      central tenet of pre-hospital care. This is of special import in an alpine setting where
      environmental factors and challenges with extrication play a significant role in patient
      outcomes (3). Despite its significance to both patient and practitioner, adequate and timely
      pain relief is often delayed. The underlying cause is multifactorial; intravenous access is
      challenging, there is limited availability of advanced health care providers and monitoring
      capabilities. To date, there remain no widespread guidelines for treatment of acute pain in
      alpine rescue and ski patrol setting.

      Intravenous (IV) opioid analgesia is widely used as a primary method of attaining pain
      control. While effective, this route of administration has several shortcomings. The
      insertion of an IV is invasive, painful,, time-consuming, exposes skin to cold injury and
      delays transport. Opioids also raise the risk of hypotension, hypoxemia and vomiting. In
      previous work (15), the intranasal (IN) route of medication delivery is rapid, effective and
      well-tolerated. In addition adverse side effects are minor and transient, and there are no
      changes in vital signs that required clinical intervention.

      This data corroborated previous research that low dose ketamine provides safe and meaningful
      analgesia while preserving cardiovascular function, respiratory drive and airway reflexes
      (27). Thus, the use of IN ketamine reduces the need for IV access in stable patients and and
      reduces the need for monitoring to the risks of opioids (6). These characteristics indicate
      great potential for ketamine in reducing the extraction and transport time of patients from
      the mountain environment.

      Intranasal ketamine is very attractive in austere and alpine environments, where monitoring
      capabilities slow transport and IV access is difficult. Previous case reports suggest that IN
      ketamine provides a rapid, easily administered and effective method of analgesia in the
      pre-hospital setting (7). However, there is no data on the feasibility of conducting a
      medical trial in a large busy commercial ski area, nor to calculate an appropriate sample
      size. The investigators propose a pilot study to investigate the feasibility of conducting a
      study of IN ketamine (INK) prior to a larger study to determine if INK provides an effective
      and safe method of analgesia for patients presenting to ski patrol with acute injuries. In
      addition, although the current body of literature shows minimal adverse events, the
      investigators will continue to study the safety of INK and monitor for any negative side
      effects. The purpose is to provide insight and information on the potential utility of IN
      ketamine in this setting, and to assess feasibility of future clinical trials powered to
      demonstrate efficacy and safety.
    

Intervention name(s): Intranasal Ketamine
Intervention type(s): Drug
Intervention description(s): Atomized Intranasal Ketamine, 50mg
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intranasal; ketamine; analgesia; mountain medicine; pre-hospital care; patient transport; pilot study; mountain environment