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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686009
First Posted: September 17, 2012
Last Update Posted: February 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
North Shore Health Research Foundation
Information provided by (Responsible Party):
Gary Andolfatto, Lions Gate Hospital
  Purpose

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.


Condition Intervention Phase
Pain Drug: Intra-nasal ketamine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-nasal Ketamine for Analgesia in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Gary Andolfatto, Lions Gate Hospital:

Primary Outcome Measures:
  • 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 Measures:
  • Median maximum reduction in VAS pain score achieved within 30 minutes [ Time Frame: 30 minutes ]
  • Median time required to achieve a 13-mm reduction in VAS pain score [ Time Frame: 1 hour ]
  • Vital signs changes (ETCO2, O2sat, HR, RR, BP) [ Time Frame: 1 hour ]
    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 [ Time Frame: 1 hour ]
    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.


Enrollment: 40
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-nasal ketamine
0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary
Drug: Intra-nasal ketamine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686009


Locations
Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Sponsors and Collaborators
Lions Gate Hospital
North Shore Health Research Foundation
Investigators
Principal Investigator: Gary Andolfatto, MD UBC Dept of EM; Lions Gate Hospital
  More Information

Responsible Party: Gary Andolfatto, Assistant Professor, University of British Columbia Department of Emergency Medicine; Attending Physician and Emergency Department Research Director, Lions Gate Hospital, Lions Gate Hospital
ClinicalTrials.gov Identifier: NCT01686009     History of Changes
Other Study ID Numbers: UBC Dept of EM
First Submitted: September 12, 2012
First Posted: September 17, 2012
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Gary Andolfatto, Lions Gate Hospital:
pain
analgesia
ketamine
intranasal
emergency

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action