Combined Ketamine/Propofol for Emergency Department Procedural Sedation

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Introduction

Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. Obviously the optimal agent or combination of agents has not been identified. There are reasons to believe that a combination of ketamine and propofol may have advantages over other agents/combinations. These include better hemodynamic stability at equal depth of anesthesia with a combination of ketamine/propofol than with propofol alone, less respiratory depression with the combination in comparison to propofol alone, and preservation of respiratory drive with the combination. There is one study of ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the safety and effectiveness of the combination, but did not compare it to any other agents or combinations. The investigators designed a randomized, placebo controlled study to compare propofol to propofol and ketamine for adequacy of sedation and respiratory depression in Emergency Department procedural sedation and analgesia. The investigators hypothesis was that the combination of propofol/ketamine would produce better sedation and/or less respiratory depression than propofol alone.

Methods

Study design

The investigators conducted a randomized, prospective, double-blinded study of all patients receiving procedural sedation. From April 2007 until July 2009 in the ED of a 274 bed university teaching hospital. The study was approved by the University of Missouri's Institutional Review Board and informed consent was obtained from all participants.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Fentanyl; Ketamine; Propofol

Criteria

Inclusion Criteria:

• Healthy individuals from 1 year of age and up without the below exclusion criteria

Exclusion Criteria:

• Subjects: All patients who require ED conscious sedation and do not meet any of the following exclusion criteria are eligible for study participation:

• Age < 1yr

• History of prior adverse reaction to anesthesia

• History of cardiac disease

• History of pulmonary disease

• Hepatic dysfunction

• Thyroid disease

• Pregnancy

• Porphyria

• Psychiatric Illness

• Allergy to eggs, soybeans, or sulfites

• Increased intracranial or intraocular pressure

• Active upper respiratory infection in children

• Abnormal airway

• ASA score of III or greater