Phase 4
N=100
Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)
Sedation
Bottom Line
View on ClinicalTrials.gov: NCT00997321 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Respiratory Depression (Sub-clinical and Clinical Signs) — 0.4; 0.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- propofol (Drug); Ketamine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hennepin Healthcare Research Institute
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Depression (Sub-clinical and Clinical Signs) |
0.4; 0.6 | — |
| SECONDARY Time to Return of Baseline Mental Status |
5; 14 | — |
| SECONDARY Patient Reported Pain or Recall of the Procedure |
0.06; 0.02 | — |
| SECONDARY Depth of Sedation |
2; 2 | — |
Summary
This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.
Eligibility Criteria
Inclusion Criteria
- patients who require moderate procedural sedation with propofol in the ED
Exclusion Criteria
- age > 17 years
- pregnant
- intoxicated
- cannot give informed consent
- allergy to ketamine or propofol
- patient will require deep procedural sedation
- ASA physical status score > 2
Data sourced from ClinicalTrials.gov (NCT00997321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.