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Intra-nasal Ketamine for Analgesia in the Emergency Department (INKA)

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Intra-nasal ketamine
Sponsored by
Lions Gate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, analgesia, ketamine, intranasal, emergency

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 6 years or greater
  • moderate or severe pain (VAS >=50mm)

Exclusion Criteria:

  • history of allergy or intolerance to ketamine
  • structural or functional nasal occlusion
  • inability to understand the VAS
  • Glasgow Coma Scale < 15
  • Systolic BP > 180
  • History of schizophrenia
  • Clinical necessity for immediate IV access as judged by the treating physician

Sites / Locations

  • Lions Gate Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra-nasal ketamine

Arm Description

0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary

Outcomes

Primary Outcome Measures

Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.

Secondary Outcome Measures

Median maximum reduction in VAS pain score achieved within 30 minutes
Median time required to achieve a 13-mm reduction in VAS pain score
Vital signs changes (ETCO2, O2sat, HR, RR, BP)
Changes in vital signs will be recorded every 5 minutes for 30 minutes, then every 10 minutes for 30 minutes
Adverse effects as defined by SERSDA
SERSDA (Side Effect Rating Scale for Dissociative Anaesthesia) includes: fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing, changes in vision, mood change, generalized discomfort, and hallucination.

Full Information

First Posted
September 12, 2012
Last Updated
February 3, 2013
Sponsor
Lions Gate Hospital
Collaborators
North Shore Health Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01686009
Brief Title
Intra-nasal Ketamine for Analgesia in the Emergency Department
Acronym
INKA
Official Title
Intra-nasal Ketamine for Analgesia in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lions Gate Hospital
Collaborators
North Shore Health Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The provision of analgesia to patients in pain is a fundamental necessity of emergency department practice and is usually accomplished using IV opioids. However, significant barriers exist to the provision of timely analgesia by the IV route. The use of the IN route for medication delivery provides an efficient and relatively painless mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid, easy-administered and well-tolerated method for providing analgesia in the ED setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, analgesia, ketamine, intranasal, emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-nasal ketamine
Arm Type
Experimental
Arm Description
0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary
Intervention Type
Drug
Intervention Name(s)
Intra-nasal ketamine
Primary Outcome Measure Information:
Title
Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Median maximum reduction in VAS pain score achieved within 30 minutes
Time Frame
30 minutes
Title
Median time required to achieve a 13-mm reduction in VAS pain score
Time Frame
1 hour
Title
Vital signs changes (ETCO2, O2sat, HR, RR, BP)
Description
Changes in vital signs will be recorded every 5 minutes for 30 minutes, then every 10 minutes for 30 minutes
Time Frame
1 hour
Title
Adverse effects as defined by SERSDA
Description
SERSDA (Side Effect Rating Scale for Dissociative Anaesthesia) includes: fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing, changes in vision, mood change, generalized discomfort, and hallucination.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 6 years or greater moderate or severe pain (VAS >=50mm) Exclusion Criteria: history of allergy or intolerance to ketamine structural or functional nasal occlusion inability to understand the VAS Glasgow Coma Scale < 15 Systolic BP > 180 History of schizophrenia Clinical necessity for immediate IV access as judged by the treating physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Andolfatto, MD
Organizational Affiliation
UBC Dept of EM; Lions Gate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada

12. IPD Sharing Statement

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Intra-nasal Ketamine for Analgesia in the Emergency Department

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