Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)

Hennepin Healthcare Research Institute100 enrolled

Overview

This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Sedation

Interventions

propofolDRUG

propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation

KetamineDRUG

ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Respiratory Depression (Sub-clinical and Clinical Signs)

binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 \>10 or an absence on capnographic waveform

Time frame: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)

Secondary Outcomes

Time to Return of Baseline Mental Status

time in seconds from the first dose of medication until the patient has regained baseline mental status

Time frame: from start of procedure until the return of baseline mental status up to 120 minutes

Patient Reported Pain or Recall of the Procedure

patient completed question after return to baseline mental status "did you feel pain during the procedure" and "do you remember any part of the procedure" answered by circling yes or no on a question sheet, positive if yes to either question

Time frame: single measurement immediately after patient returns to baseline mental status after sedation procedure

Depth of Sedation

Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain

Time frame: single measurement during sedation procedure

Data from ClinicalTrials.gov

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