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Hennepin Healthcare suspends a clinical trial on sedative ketamine in emergency situations following criticism that its hospital, the Hennepin County Medical Center, has recruited patients into the study without their knowledge.
The use of sedation by paramedics on agitated people during emergency calls is already the subject of an independent investigation commissioned by the city of Minneapolis. The number of documented ketamine injections during police calls rose from three in 2012 to 62 last year, according to a Minneapolis Police Bureau investigation.
Researchers at Hennepin County Hospital are trying to determine which of the drugs already used to treat agitation – including ketamine – are the most effective. The study began last August. It does not require any prior consent of patients, who may withdraw.
State Judge Jeff Hayden and Hennepin County Commissioner Peter McLaughlin on Monday called the clinical trial of the hospital unethical.
"While we understand that Hennepin Healthcare has followed federal research procedures, we believe that an urban hospital that treats a large number of low-income people of color and Minnesota must take extra precautions," said the Hayden and McLaughlin release. "Nothing less than ignores the history of abuse of these communities as test subjects for new drugs and medical procedures, which is unacceptable, we can and must do better."
Hospital doctors advocate the drug as an essential tool for treating agitated and aggressive patients and have stated that their consent procedures are legal and ethical.
"Whenever we interact with EMS about it, we stress to them, limpid: Under no circumstances will the study ever increase the number of sedations," said Dr. Jon Cole, Emergency Physician and toxicologist at Hennepin Healthcare.
Former US Attorney General Sally Yates is leading the independent investigation into the Minneapolis Police Department's protocols and interactions with local emergency management services staff.
Hospital officials were asked to provide a report on the study to the Hennepin County Council on Tuesday.
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