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

This study has been completed.
Sponsor:
Collaborator:
North Shore Health Research Foundation
Information provided by (Responsible Party):
Gary Andolfatto, Lions Gate Hospital
ClinicalTrials.gov Identifier:
NCT01686009
First received: September 12, 2012
Last updated: February 3, 2013
Last verified: February 2013
History of Changes

September 12, 2012
February 3, 2013
October 2012
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01686009 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Intra-nasal Ketamine for Analgesia in the Emergency Department
Intra-nasal Ketamine for Analgesia in the Emergency Department

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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Intra-nasal ketamine
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01686009
UBC Dept of EM
No
Gary Andolfatto, Lions Gate Hospital
Lions Gate Hospital
North Shore Health Research Foundation
Principal Investigator: Gary Andolfatto, MD UBC Dept of EM; Lions Gate Hospital
Lions Gate Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP