CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 271 enrolled
Drug / intervention
Propofol +2 moredrug
Likely dose
Propofol 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01260662
NCT01260662Phase 4Completed

Randomized Blinded Three Arm Trial of Propofol, 1:1 Combination of Propofol and Ketamine, and 4:1 Combination of Propofol and Ketamine for Procedural Sedation in the Emergency Department

Hennepin Healthcare Research Institute·interventional·Posted Dec 15, 2010·Updated Jul 14, 2015

In Brief

A Phase 4 clinical trial evaluating Propofol, 1:1 Propofol/Ketamine, and 1 other intervention for Procedural Sedation. Completed, enrolled 271 participants across 1 site.

Detailed Summary

This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided. In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2010
Enrollment StartNov 1, 2010
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.5 years ago

Interventions

Propofoldrug

1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation

1:1 Propofol/Ketaminedrug

Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation

4:1 Propofol/Ketaminedrug

Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation