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Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial

NCT01269307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2014-12-12

No results posted yet for this study

Summary

The purpose of this study is to determine if procedural sedation utilizing a 1:1 mixture of propofol and ketamine is equivalent in complications, patient and physician satisfaction, post-procedure pain level, and procedural outcome to propofol sedation alone.

Conditions

  • Sedation

Interventions

PROCEDURE

1:1 ketamine-propofol mixture sedation

Prepare Ketamine and Propofol 10mg/cc of ketamine 10mg/cc of propofol mix 1:1 in 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus. Repeat dose 0.025 - 0.05 every 60-90 seconds as needed to reach and maintain target level of sedation. May round to nearest 0.5-1 cc. Note - 1 cc = 5mg of propofol and 5mg of ketamine

PROCEDURE

Propofol Sedation

Prepare Propofol 10mg/cc of propofol 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus over 30 seconds. Repeat dose 0.025 - 0.05 cc/kg every 30-60 seconds as needed to reach and maintain target level of sedation. May round to nearest 0.5 cc Note - 1 cc = 10 mg of propofol

Sponsors & Collaborators

Principal Investigators

  • Scott Youngquist, MD MSc · University of Utah

  • Virgil Davis, MD · University of Utah

  • Troy Madsen, MD · University of Utah

  • Anas Sawas, MS MPH · University of Utah

  • Matthew Ahern, DO · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269307 on ClinicalTrials.gov