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.
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.
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:
- Is our study protocol feasible to study INK in a mountain, prehospital care environment?
- What estimate can be made of recruitment rates?
- Does studying the use of INK interfere with or delay care at Whistler/Blackcomb?
- Is intra-nasal ketamine an effective and safe method for controlling pain in our study population and setting?
- Does intranasal ketamine provide a clinically significant reduction in pain or do patients require additional IV narcotics for extraction?
- Are there any significant changes in vital signs after administration of intra-nasal ketamine
- Does the use of intra-nasal ketamine reduce time of patient extraction and transport in the alpine pre-hospital setting?
- 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.
- Conditions
- Pain, Traumatic Limb Injury
- 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 group | Role | What they receive |
|---|---|---|
| Intranasal Ketamine | Experimental | All patients Receives: Drug: Intranasal Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesia
clinical effect of intranasal ketamine on pain score measured by verbal analogue scale
Measured: 30 minutes
Secondary outcomes (3)
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
cardiorespiratory stability
effect of ketamine on heart rate, blood pressure, respiratory rate and oxygen saturation
Measured: 30 minutes
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.
- First posted10 Jan 2014 (estimated)
- Study start1 Mar 2014
- Primary completion15 May 2016
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Dr. Greg Haljan, University of Calgary
- Investigators
- Gary Andolfatto, MD, Principal investigator, University of British Columbia
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-hospital Care With Intra-Nasal Ketamine for Transport (PRECINKT): A Pilot Study
- ClinicalTrials.gov ID
- NCT02033434
- Acronym / sponsor ID
- PRECINKT / PRECINKT-001
- Conditions
- Pain, Traumatic Limb Injury
- Keywords
- intranasal, ketamine, analgesia, mountain medicine, pre-hospital care, patient transport, pilot study, mountain environment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is our study protocol feasible to study INK in a mountain, prehospital care environment?
- What estimate can be made of recruitment rates?
- Does studying the use of INK interfere with or delay care at Whistler/Blackcomb?
- Is intra-nasal ketamine an effective and safe method for controlling pain in our study population and setting?
- Does intranasal ketamine provide a clinically significant reduction in pain or do patients require additional IV narcotics for extraction?
- Are there any significant changes in vital signs after administration of intra-nasal ketamine
- Does the use of intra-nasal ketamine reduce time of patient extraction and transport in the alpine pre-hospital setting?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal Ketamine | Experimental | Drug: Intranasal KetamineAll patients |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- traumatic extremity injury
- age greater than 18 years old
- moderate or severe pain (VNRS 5 or greater)
Key exclusion criteria (10 listed)
- need for an intravenous catheter as judged by treating physician
- pregnancy
- unable to speak English
- shoulder dislocations,
- previous hypersensitivity, intolerance, or allergy to ketamine,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal KetamineAtomized Intranasal Ketamine, 50mg | Drug | Intranasal Ketamine |
Primary outcome
analgesia
Time frame: 30 minutes
clinical effect of intranasal ketamine on pain score measured by verbal analogue scale
3 secondary outcomes
transport time
Time frame: 60 minutes
cardiorespiratory stability
Time frame: 30 minutes
Satisfaction with medical care and evacuation
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Andolfatto, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
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.