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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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.
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
|Canada, British Columbia|
|Lions Gate Hospital|
|North Vancouver, British Columbia, Canada, V7L 2L7|
|Principal Investigator:||Gary Andolfatto, MD||UBC Dept of EM; Lions Gate Hospital|