Pain Medicine for Wound Care Procedures
Condition: Wound Care; Pain Intensity; Hyperalgesia; Nausea; Vomiting; Hallucinations
MeSH terms: Hyperalgesia; Hallucinations; Nausea; Vomiting; Pain; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): morphine plus saline; morphine plus ketamine
Intervention type(s): Drug; Drug
Intervention description(s): During the first wound care procedure, some patients will receive morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline (MS), according to randomization, while other patients will receive morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg; Patients who received morphine 0.1 mg/kg (maximum dose of 8 mg)plus saline during the first wound care procedure will now receive ketamine 0.25 mg/kg IV plus morphine 0.05 mg/kg
Intervention MeSH terms: Ketamine; Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: wound care; procedural pain intensity; procedural hyperalgesia; wound care pain intensity; wound care hyperalgesia; Wound care pain quality; Level of drowsiness; level of nausea; Level of vomiting; Level of hallucinations; Level of dysphoria