Pain
Conditions
Keywords
pain, analgesia, ketamine, intranasal, emergency
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.
Interventions
DRUGIntra-nasal ketamine
Sponsors
North Shore Health Research Foundation
Lions Gate Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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. |
Countries
Canada
Outcome results
None listed