Intra-nasal Ketamine for Analgesia in the Emergency Department

Ketamine

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.

Intervention / Treatment

  • Intra-nasal ketamine (DRUG)
    N/A

Condition or Disease

  • Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 6 Years and older   (Child, Adult, Older Adult)
    Enrollment: 40 (ACTUAL)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Oct 01, 2012
    Primary Completion: Jan 01, 2013 ACTUAL
    Completion Date: Jan 01, 2013 ACTUAL
    Study First Posted: Sep 17, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 03, 2013

    Sponsors / Collaborators

    Lead Sponsor: Lions Gate Hospital
    Responsible Party: N/A

    Location

    North Vancouver, British Columbia, Canada

    Participant Groups

    • 0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary

    Eligibility Criteria

    Sex: All
    Minimum Age: 6
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes. 30 minutes
    Secondary Outcomes
    • Median maximum reduction in VAS pain score achieved within 30 minutes 30 minutes
    • Median time required to achieve a 13-mm reduction in VAS pain score 1 hour

    • Changes in vital signs will be recorded every 5 minutes for 30 minutes, then every 10 minutes for 30 minutes

    • 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.

    More Details

    NCT Number: NCT01686009
    Acronym: INKA
    Other IDs: UBC Dept of EM
    Study URL: https://clinicaltrials.gov/study/NCT01686009
    Last updated: Sep 29, 2023