A Phase 3 interventional study of Morphine plus Ketamine and Morphine plus Saline (placebo) in Wound Care, Pain Intensity and Hyperalgesia, sponsored by University of California, San Francisco. Completed at 2 sites in 2 countries. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by University of California, San Francisco · Phase 3, Interventional, and Treatment
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 12 is below the median of 66 across 8,493 interventional studies indexed under Pain.
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Exclusion Criteria:
During the first wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK). Then, during the second wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline (MS).
Drug: Morphine plus Ketamine · Drug: Morphine plus Saline (placebo)
During the first wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline (MS). Then, during the second wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4mg) plus ketamine 0.25 mg/kg (MK)
Drug: Morphine plus Ketamine · Drug: Morphine plus Saline (placebo)
Drug pages: Morphine · Ketamine
Morphine 0.05 mg/kg (maximum dose of 4 mg) IV plus Ketamine 0.25 mg/kg IV. Then, Morphine 0.1 mg/kg (maximum dose of 8 mg) IV plus Saline IV
Morphine 0.1 mg/kg (maximum dose of 8 mg) IV plus Saline IV. Then, Morphine 0.05 mg/kg (maximum dose of 4 mg) IV plus Ketamine 0.25 mg/kg IV.
Pain Intensity
The degree of pain described by participants on a numeric rating scale of 0 to 10, where 0 = no pain and 10 = worst pain imaginable
Time frame: Immediately after the wound care procedure
Wound Pain Quality
Short-form McGill Pain Questionnaire. The questionnaire has 15 adjectives to describe the pain. Each is rated on a 4-point scale (i.e., none, mild, moderate, or severe. Total wound pain quality score can range from 0 to 45.
Time frame: Immediately after the procedure
| Milestone | Morphine Plus Ketamine, Then Morphine Plus Saline | Morphine Plus Saline, Then Morphine Plus Ketamine |
|---|---|---|
| Started | 7 | 5 |
| Completed | 7 | 4 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
The degree of pain described by participants on a numeric rating scale of 0 to 10, where 0 = no pain and 10 = worst pain imaginable
| score on a scale | Morphine Plus Ketamine | Morphine Plus Saline |
|---|---|---|
| Pain Intensity | 3.1 ± .99 | 6.8 ± .92 |
Short-form McGill Pain Questionnaire. The questionnaire has 15 adjectives to describe the pain. Each is rated on a 4-point scale (i.e., none, mild, moderate, or severe. Total wound pain quality score can range from 0 to 45.
| units on a scale | Morphine Plus Ketamine | Morphine Plus Saline |
|---|---|---|
| Wound Pain Quality | 13.6 ± 3.6 | 17.6 ± 3.7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Morphine Plus Ketamine | — | 0/11 (0%) | 10/11 (90.9%) |
| Morphine Plus Saline | — | 0/11 (0%) | 0/11 (0%) |
| Event | Morphine Plus Ketamine | Morphine Plus Saline |
|---|---|---|
| strange sensationsNervous system disorders | 10/11 | 0/11 |
| Age, Continuous(years) | Morphine Plus Ketamine First | Morphine Plus Saline First | Total |
|---|---|---|---|
| Mean | 32.1 ± 9.6 | 32.5 ± 4.4 | 32.3 ± 7.8 |
| Sex: Female, Male(Participants) | Morphine Plus Ketamine First | Morphine Plus Saline First | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 7 | 4 | 11 |
| Region of Enrollment(participants) | Morphine Plus Ketamine First | Morphine Plus Saline First | Total |
|---|---|---|---|
| Puerto Rico | 7 | 4 | 11 |
Plan to share: No
The record gives a start of Jun 2008, a primary completion of Apr 2009 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2024, 14 years 11 months after primary completion.
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Studies of the drugs tested here: Morphine · Ketamine
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