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

NCT02033434 | Completed Phase 1 DMC

• 1 other identifier: PRECINKT-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pain; Traumatic Limb Injury

Keywords

intranasal; ketamine; analgesia; mountain medicine; pre-hospital care; patient transport; pilot study; mountain environment

Outcome Measures

Primary Outcomes (1)

• analgesia

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

  30 minutes

Secondary Outcomes (3)

• transport time

  60 minutes

• cardiorespiratory stability

  30 minutes

• Satisfaction with medical care and evacuation

  1 week

Study Arms (1)

Intranasal Ketamine

EXPERIMENTAL

All patients

Drug: Intranasal Ketamine

Interventions

Intranasal Ketamine DRUG

Atomized Intranasal Ketamine, 50mg

Intranasal Ketamine

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,
• inability to understand the VNRS,
• Glasgow Coma Scale \<15,
• inability to give informed consent
• history of schizophrenia

Sponsors & Collaborators

• University of Calgary: lead
• University of British Columbia: collaborator

Study Sites (1)

Whistler Blackcomb

Whistler, British Columbia, V0N 1B4, Canada

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Gary Andolfatto, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal Investigator

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: January 10, 2014
• Study Start: March 1, 2014
• Primary Completion: May 15, 2016
• Study Completion: September 1, 2017
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

CA (1)