Intra-nasal Ketamine for Analgesia in the Emergency Department

Study Overview
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Brief Summary
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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.

Official Title
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Intra-nasal Ketamine for Analgesia in the Emergency Department

Conditions
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Pain

Intervention / Treatment
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* Drug: Intra-nasal ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-nasal ketamine<br>0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary | Drug: Intra-nasal ketamine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes. |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Vital signs changes (ETCO2, O2sat, HR, RR, BP) | Changes in vital signs will be recorded every 5 minutes for 30 minutes, then every 10 minutes for 30 minutes | 1 hour | 
| Adverse effects as defined by SERSDA | 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. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, analgesia, ketamine, intranasal, emergency