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PainPhase 1PRECINKTNCT02033434

Pre-hospital Care With Intra-Nasal Ketamine for Transport (PRECINKT): A Pilot Study

A Phase 1 study testing Intranasal Ketamine in people with Pain and Traumatic Limb Injury, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Pain, Traumatic Limb Injury
What is being tested?
Intranasal Ketamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
1 Mar 2014to 1 Sep 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • traumatic extremity injury
  • age greater than 18 years old
  • moderate or severe pain (VNRS 5 or greater)

Who cannot join

  • need for an intravenous catheter as judged by treating physician
  • pregnancy
  • unable to speak English
  • shoulder dislocations,
  • previous hypersensitivity, intolerance, or allergy to ketamine,
  • structural or functional nasal occlusion,
Show all 10Show fewer
  • inability to understand the VNRS,
  • Glasgow Coma Scale <15,
  • inability to give informed consent
  • history of schizophrenia

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Whistler Blackcomb

    Whistler, British Columbia, V0N 1B4

Other trials in Canada

About this study

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?
Read the 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.

Being tested
Intranasal Ketamine
Keywords
intranasal, ketamine, analgesia, mountain medicine, pre-hospital care, patient transport, pilot study, mountain environment
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intranasal KetamineDrug

    Atomized Intranasal Ketamine, 50mg

Study groups in NCT02033434
Study groupRoleWhat they receive
Intranasal KetamineExperimentalAll patients
Receives: Drug: Intranasal Ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. analgesia

    clinical effect of intranasal ketamine on pain score measured by verbal analogue scale

    Measured: 30 minutes

Secondary outcomes (3)
  1. transport time

    the transport time from arrival of first responder to arrival at ambulance pick-up will be compared to historical controls.

    Measured: 60 minutes

  2. cardiorespiratory stability

    effect of ketamine on heart rate, blood pressure, respiratory rate and oxygen saturation

    Measured: 30 minutes

  3. Satisfaction with medical care and evacuation

    Patient, first responder and clinician satisfaction with study protocol and analgesia

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2014 (estimated)
  2. Study start1 Mar 2014
  3. Primary completion15 May 2016
  4. Study completion1 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02033434
Sponsor's protocol ID
PRECINKT-001
Acronym
PRECINKT
Status last verified
Sep 2019
First submitted
13 Dec 2013
Last updated
26 Sep 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intranasal Ketamine in people with Pain and Traumatic Limb Injury, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

analgesia (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.

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