Intra-nasal Ketamine for Analgesia in the Emergency Department (INKA)
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ClinicalTrials.gov Identifier: NCT01686009 |
Recruitment Status :
Completed
First Posted : September 17, 2012
Last Update Posted : February 5, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | September 12, 2012 | |||
First Posted Date ICMJE | September 17, 2012 | |||
Last Update Posted Date | February 5, 2013 | |||
Study Start Date ICMJE | October 2012 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Intra-nasal Ketamine for Analgesia in the Emergency Department | |||
Official Title ICMJE | Intra-nasal Ketamine for Analgesia in the Emergency Department | |||
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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Pain | |||
Intervention ICMJE | Drug: Intra-nasal ketamine | |||
Study Arms ICMJE | Experimental: Intra-nasal ketamine
0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary
Intervention: Drug: Intra-nasal ketamine
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2013 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01686009 | |||
Other Study ID Numbers ICMJE | UBC Dept of EM | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Gary Andolfatto, Lions Gate Hospital | |||
Study Sponsor ICMJE | Lions Gate Hospital | |||
Collaborators ICMJE | North Shore Health Research Foundation | |||
Investigators ICMJE |
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PRS Account | Lions Gate Hospital | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |