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

Tracking Information
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; (submitted: September 12, 2012)	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	Complete list of historical versions of study NCT01686009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 12, 2012)	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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Pain
Intervention ICMJE	Drug: Intra-nasal ketamine
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 12, 2012)	40
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	January 2013
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	6 Years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Gary Andolfatto, Lions Gate Hospital
Study Sponsor ICMJE	Lions Gate Hospital
Collaborators ICMJE	North Shore Health Research Foundation
Investigators ICMJE	Principal Investigator: Gary Andolfatto, MD UBC Dept of EM; Lions Gate Hospital
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