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

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. Identifier: NCT01686009
Recruitment Status : Completed
First Posted : September 17, 2012
Last Update Posted : February 5, 2013
North Shore Health Research Foundation
Information provided by (Responsible Party):
Gary Andolfatto, Lions Gate Hospital

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Intra-nasal ketamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-nasal Ketamine for Analgesia in the Emergency Department
Study Start Date : October 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Median maximum reduction in VAS pain score achieved within 30 minutes [ Time Frame: 30 minutes ]
  2. Median time required to achieve a 13-mm reduction in VAS pain score [ Time Frame: 1 hour ]
  3. 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

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01686009

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

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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 Identifier: NCT01686009     History of Changes
Other Study ID Numbers: UBC Dept of EM
First Posted: September 17, 2012    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Keywords provided by Gary Andolfatto, Lions Gate Hospital:
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action