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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00701909 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Wound Care Pain Intensity Hyperalgesia Nausea Vomiting Hallucinations |
Drug: morphine plus saline Drug: morphine plus ketamine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | The Effectiveness of Small Doses of Ketamine With Morphine on Decreasing Pain Responses During Open Wound Care |
| Enrollment: | 12 |
| Study Start Date: | June 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
During the first wound care procedure, patients will receive either morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline (MS) or morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK) before the WCP according to randomization. During the second wound care procedure, they will receive the drugs and doses that they had not received the first time.
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Drug: morphine plus saline
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
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2: Active Comparator
During the second wound care procedure, patients will receive either morphine 0.1 mg/kg (maximum dose of 8 mg) plus saline (MS) or morphine 0.05 mg/kg (maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK), whichever drugs and doses that they had not received the first time.
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Drug: morphine plus ketamine
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
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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.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Puerto Rico | |
| Trauma Unit University of Puerto Rico Medical Center | |
| San Juan, Puerto Rico | |
| Study Chair: | Kathleen A Puntillo, RN, DNSc | Regents of the University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco ( Kathleen Puntillo ) |
| Study ID Numbers: | H2280-32187-01 |
| Study First Received: | June 18, 2008 |
| Last Updated: | January 15, 2010 |
| ClinicalTrials.gov Identifier: | NCT00701909 History of Changes |
| Health Authority: | United States: UCSF School of Nursing doctoral dissertation committee for Carmen Mabel Arroyo |
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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 |
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Sensation Disorders Neurotransmitter Agents Vomiting Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Hallucinations Physiological Effects of Drugs Anesthetics Excitatory Amino Acid Agents Somatosensory Disorders Signs and Symptoms Sensory System Agents Therapeutic Uses Ketamine Nausea |
Analgesics Neurobehavioral Manifestations Analgesics, Opioid Excitatory Amino Acid Antagonists Anesthetics, Intravenous Morphine Nervous System Diseases Central Nervous System Depressants Narcotics Hyperalgesia Anesthetics, Dissociative Pharmacologic Actions Anesthetics, General Neurologic Manifestations Peripheral Nervous System Agents |
