Ketofol vs Propofol for Emergency Department Procedural Sedation and Analgesia
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Lions Gate Hospital
Collaborators:
University of British Columbia Vancouver Coastal Health Research Institute