Intra-nasal Ketamine for Analgesia in the Emergency Department (INKA)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intra-nasal Ketamine for Analgesia in the Emergency Department|
- 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 ] [ Designated as safety issue: No ]
- Median maximum reduction in VAS pain score achieved within 30 minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- Median time required to achieve a 13-mm reduction in VAS pain score [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Vital signs changes (ETCO2, O2sat, HR, RR, BP) [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: 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|