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

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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE 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  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
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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
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
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