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Intranasal ketamine for prehospital acute pain
NCT02753114Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2017
- Primary completion
- May 2018
- Countries
- 1
- Sponsor
- University of British Columbia
- Modality
- Small Molecules
- Drugs
- ketamine
- Conditions
- acute pain
01
Overview
Phase 4, randomised, double-blind trial in acute pain comparing Intranasal Ketamine with Placebo (2 arms). Primary endpoint: Proportion experiencing 2-point or more pain score reduction at 30 minutes. Started Nov 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Intranasal Ketamine
Ketamine + Nitrous Oxide
Placebo
Saline + Nitrous Oxide
03
Who it enrols
Adult patients with acute pain (NRS >= 5) requiring prehospital transport and eligible for nitrous oxide.
04
Endpoints
Primary
Proportion experiencing 2-point or more pain score reduction at 30 minutes
Secondary
Proportion experiencing 2-point or more pain score reduction at 15 minutes
Proportion of patients feeling 'a lot better' or 'moderately better' at 30 minutes
Proportion of patients feeling 'a lot better' or 'moderately better' at 15 minutes
Proportion of patients feeling 'a lot better', 'moderately better' or 'a little better' at 15 and 30 minutes
Adverse Events
Patient Satisfaction
Provider Satisfaction
Median Nitrous Oxide Consumption
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