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临床试验/NCT00701909
NCT00701909已完成3 期

The Effectiveness of Small Doses of Ketamine With Morphine on Decreasing Pain Responses During Open Wound Care

University of California, San Francisco2 个研究点 分布在 2 个国家目标入组 12 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
12
试验地点
2
主要终点
Pain Intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients (≥ 21 years) have to have an open wound with duration of no more than 10 days that requires wound care
  • be able to self-report their pain
  • had a pain intensity score > 3 during previous wound care procedure
  • has intravenous access

排除标准

  • Patients with an injury that impairs sensation in the wound area according to a medical diagnosis
  • has an allergy to morphine or ketamine
  • has not received morphine previously
  • In addition, patients who are 65 years of age or older.

研究组 & 干预措施

Morphine plus Ketamine, then Morphine plus Saline (placebo)

Active Comparator

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).

干预措施: Morphine plus Ketamine (Drug)

Morphine plus Ketamine, then Morphine plus Saline (placebo)

Active Comparator

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).

干预措施: Morphine plus Saline (placebo) (Drug)

Morphine plus Saline (placebo), then Morphine plus Ketamine

Placebo Comparator

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)

干预措施: Morphine plus Ketamine (Drug)

Morphine plus Saline (placebo), then Morphine plus Ketamine

Placebo Comparator

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)

干预措施: Morphine plus Saline (placebo) (Drug)

结局指标

主要结局

Pain Intensity

时间窗: Immediately after the wound care procedure

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

次要结局

  • Wound Pain Quality(Immediately after the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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