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

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

Tracking Information

• First Submitted Date: September 12, 2012
• First Posted Date: September 17, 2012
• Last Update Posted Date: February 5, 2013
• Study Start Date: October 2012
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intra-nasal Ketamine for Analgesia in the Emergency Department
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pain
• Intervention: 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2012): 40
• Original Estimated Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01686009
• Other Study ID Numbers: UBC Dept of EM
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gary Andolfatto, Lions Gate Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Lions Gate Hospital
• Original Study Sponsor: Same as current
• Collaborators: North Shore Health Research Foundation

Investigators

• Principal Investigator: Gary Andolfatto, MD; UBC Dept of EM; Lions Gate Hospital

• PRS Account: Lions Gate Hospital
• Verification Date: February 2013