Most of us know someone who suffers from the excruciating pain of a migraine. According to the Migraine Research Foundation, these headaches are the third most prevalent illness in the world and the sixth most debilitating.
Ashley Etchison, a fourth-year student at the Virginia Tech Carilion School of Medicine, set out to determine the effectiveness of a drug called ketamine for the treatment of migraines, something that had never been studied. Her project opened the door to a new area of research and produced a few interesting results along the way.
Ketamine is a medication mainly used for sedation or anesthesia in surgical procedures. It is also used at lower doses for pain control outside the surgical setting. Studies have shown ketamine works well for abdominal and musculoskeletal pain.
In recent years, some providers have been administering ketamine for migraine pain, and Etchison wanted to validate its efficacy for migraines by studying its effectiveness in a controlled setting for patients entering the Emergency Department at Carilion Roanoke Memorial Hospital. The best way to test it was to give some of them ketamine and others a placebo.
“One of the biggest hurdles we had to overcome early on was getting approval from the Institutional Review Board (IRB) to conduct the study,” she said. “There was definitely an ethical consideration because we were going to administer a placebo to some of our study participants. We wanted a study that was scientifically sound in its design, but we didn’t want participants to be suffering. There were a lot of discussions with the IRB about what amount of time would be ethically reasonable, and together we decided on 30 minutes.”
In her sample of 35 subjects, half received intravenous ketamine, and half received a placebo of saline solution. The subjects, researchers, and health care providers did not know which was being administered.
Information was collected on each particpant at the time of drug administration of the drug and again 30 minutes later. A participant’s Numeric Rating Scale for pain, a 1-10 scale commonly used in pain studies, was the primary outcome Etchison measured. Secondary outcomes included categorical pain, functional disability, side effects, a participant’s satisfaction and whether they made a request for additional pain relief during the first 30 minutes. If the latter request was made, they were given pain medication immediately.
Etchison credits Lia Manfredi, also a fourth-year student, who worked with her during the first two years of the study before switching to a different project.
“Lia and I spent hours developing protocols,” she said. “Then when we started collecting data. It was a total team effort with help also from classmate Vu Phan, research assistants, and health care personnel.”
In the end, Etchison determined ketamine was not superior to the placebo. In fact, the two treatments performed similarly on the subjects enrolled in the study.
“Initially, we were sold on the fact that ketamine would work,” she said. “We thought giving a medication that has been shown in the literature to improve pain in other areas of the body would work for migraines. We were surprised when it didn’t work, but we were able to add data from a well-controlled study to a new area of research. Since the drug has never been used before in this specific migraine population, it leaves the door open for future studies.”
In addition, the study revealed that within 30 minutes, subjects who received ketamine reported few side effects.
“The take away is that at least in this population ketamine was fairly safe, although not particularly more effective than a placebo for relieving migraine pain” Etchison said. “The safety aspect has not been shown in the emergency department previously, so we can add that to the literature.”
Etchison said the most surprising outcome of her study was how strongly the placebo effect revealed itself. Some possible side effects of ketamine include hallucinations and feelings of depression. Surprisingly, the only subjects who reported these neuropsychiatric side effects turned out to be those who received the placebo.
Since 2010, when the medical school opened, students have given more than 250 presentations of their research at regional, national, or international meetings. Etchison has presented her work twice, once at the European Congress of Emergency Medicine in Athens, Greece; the other at the American College of Emergency Physicians Scientific Assembly in Washington, D.C.
“The stringent research requirement strongly influenced my desire to come to VTCSOM,” she said. “In the end, it added such a huge positive dimension to my overall medical school experience. I think it shaped me not only as a future clinician, but also a researcher, and I think those two things together are going to make me a better doctor.”
Having received a Letter of Distinction for her project, Etchison will be one of eight students from the class of 2018 giving oral presentations as part of the VTCSOM Medical Student Research Symposium. In addition, the rest of the class will be giving poster presentations at the event, which will be held during the afternoon of March 23. Read more.