Ketofol vs Propofol for Emergency Department Procedural Sedation and Analgesia

Summary

When patients come to the Emergency Department with injuries and infections they often need to have painful procedures performed that are essential to allowing them to recover. To accomplish this, doctors often use "procedural sedation". This involves giving medications through an intravenous line in order to relieve the patient's pain and to make them drowsy while the painful procedure is being performed. This allows the medical staff to perform necessary procedures to patients without causing pain and anguish.

There are several types of medications and combinations of medications that are used for procedural sedation. Each medication has its advantages and its disadvantages. Consequently, research is necessary to determine which medication or combination of medications is the most effective and the safest. This study will compare the use of one drug (Propofol) versus the use of a combination of Propofol with another drug (Ketamine). Both of these drugs are already used for procedural sedations in the emergency department but it is not known which of them is the best or the safest.

The investigators believe that the combination of ketamine and propofol together will work as good or better than propofol alone and be a safer option as well. Propofol is a well known sedative that is used in many emergency departments and the clinical experience with it has been very good because it acts quickly and wears off quickly. However, propofol is not a good pain-killer and it can also cause patients to stop breathing. This is why monitoring a patient's breathing and vital signs is essential for any procedural sedation. It is known that ketamine is a good pain-killer and helps patients to maintain their breathing. Doctors sometimes use ketamine alone for procedural sedation but patients take a very long time to wake up when ketamine only is used.

Thus, the investigators think that by combining ketamine with propofol the investigators can perform painful procedures using procedural sedation without causing patients to stop breathing as often as with propofol alone. Also, the ketamine the investigators use will help treat their pain and make them more comfortable.

The investigators plan to enroll 284 patients over the course of about one year. The primary outcome of adverse respiratory events, as well as the secondary outcomes will be assessed during the course of the sedation and recovery period, approximately one hour. Quality of life score and pain will be assessed by telephone interview 3 days after the procedure.

Conditions

• Emergency Department Procedural Sedation
• Fracture Reduction
• Abscess Incision and Drainage
• Electrical Cardioversion

Interventions

DRUG

Ketofol

Syringes containing ketofol (mixed propofol-ketamine) will contain propofol 5mg/ml and ketamine 5 mg/ml. Patients will receive an initial intravenous dose of 0.075 millilitres per kilogram of pre-prepared medication. Patients in the propofol-ketamine group will receive 0.375 mg/kg each of ketamine and propofol as an initial bolus and 0.188 mg/kg each of ketamine and propofol as necessary until reaching deep sedation (Ramsay score = 5 or greater).

DRUG

Propofol alone

Propofol-only syringes will contain propofol 10 mg/ml. Patients in each group will receive an initial intravenous dose of 0.075 millilitres per kilogram of pre-prepared medication (0.75 mg/kg). One minute after the initial dose of sedative, and every minute thereafter, the attending physician will assess the patient's level of sedation using the Ramsay Sedation Scale (RSS). If the attending physician determines the level of sedation to be inadequate (RSS\<5), additional study drug will be administered at a dose of 0.0375 millilitres per kilogram (0.375 mg/kg) every minute until deep sedation is achieved (RSS=5 or greater).

Sponsors & Collaborators

• Vancouver Coastal Health Research Institute

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Lions Gate Hospital

  lead OTHER

Principal Investigators

• Gary Andolfatto, MD · Lions Gate Hospital, University of British Columbia Department of Emergency Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• Canada

Study Locations