Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00701909 |
| Other study ID # |
H2280-32187-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
June 2008 |
| Est. completion date |
April 2009 |
Study information
| Verified date |
March 2024 |
| Source |
University of California, San Francisco |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a randomized double-blind study to determine if the administration of a small-dose of
ketamine (an anesthetic)added to morphine (an opioid) contributes to reducing pain intensity
during open wound care procedure (WCP)in patients who have had a traumatic injury and are in
an Intensive Care Unit. Patients will be randomized to receive morphine plus saline (a
placebo) or morphine plus ketamine before the WCP. The second time the patient is scheduled
for WCP (no less than 24 hours), patients will be crossed over to receive the treatment they
did not receive the first time. It is hypothesized that patients who receive the combination
of morphine and ketamine will have better pain control during the procedure than patients who
just receive morphine.
Description:
An open wound care procedure causes pain and sometimes the use of medication such as morphine
alone does not adequately help to alleviate pain during this procedure. This study is being
done to learn if the administration of another medication named ketamine by the vein in
addition to morphine is more effective in alleviating pain during the wound cleansing
procedure than the administration of morphine alone. Patients will be eligible for the study
if they are 21 years and older, have an open surgical or traumatic wound with a duration of
no more than 10 days, had a wound pain intensity score more than 3 in a scale of 0 to 10
where 0 is no pain and 10 is the worst pain imaginable during a previous wound care
procedure, and have an intravenous access.
A total of 50 patients with these same characteristics are expected to take part in this
study. Patients who agree to take part in this study will, one day, receive receive an
injection via the vein of morphine 0.05 mg per kilogram of their weight (maximum dose of 4
mg) and another of ketamine 0.25 mg per kilogram of their weight prior receiving the wound
care procedure and, on the other day, will receive an injection via the vein of morphine 0.1
mg per kilogram of their weight (maximum dose of 8 mg) and another of saline prior receiving
the wound care procedure. They will not be able to know if they receive ketamine or saline
the first time or second time.
Ketamine is a drug approved by the U.S. Food and Drug Administration (FDA) for anesthesia but
not approved to provide analgesia (relieve pain). However, small doses of ketamine are used
(out of its indications) in the clinical area to provide analgesia, and its analgesic
properties have been studied by many researchers.
Before the wound care procedure subjects will be asked to rate their wound pain intensity at
rest at that moment and in the past 24 hours (including "worst" and "average" pain), overall
pain intensity at rest at this moment and "worst" and "average" in the past 24 hours using a
0 to 10 scale where 0 is no pain and 10 is the worst pain imaginable. They will be given a
list of common words that might describe their pain, and a body outline to indicate where the
pain is. In addition, they will be asked to rate their level of sleepiness using a 0 to 10
scale where 0 is not at all sleepy and 10 is extremely sleepy.
After removing the outer dressing, patients will be tested for pain sensitivity around the
wound with a thin, short length of plastic (like a little straw), which will be pressed
against their skin from the outside of the wound towards the wound and they will be asked to
report a distinct change in perception. The first point where a "painful", "sore", or
"sharper" feeling occurs will be marked in the skin to measure the distance of this mark to
the wound. If no change in perception occurs, stimulation will be stopped 0.5 cm from the
wound. This measure is experimental.
Immediately after the wound care procedure the following will be measured: (1) "worst" wound
pain intensity experienced during the wound care procedure, (2) description of pain quality
during the wound care procedure, (3) level of sleepiness, (4) side effects such as unpleasant
sensation will be measured using a 0 to 10 scale, where 0 means no unpleasant sensation at
all and 10 means extremely unpleasant sensation, and finally (5) pain sensitivity around the
wound using a thin, short length of plastic.
The length of time needed to take part in this study will depend on how long the wound care
procedure takes. The time could be approximately 45 minutes to 60 minutes (1 hour) per visit
and 90 minutes (1½ hour) to 120 minutes (2 hours) in total for the study because 2 days are
needed to complete the study.
