Patients sedated by ketamine were enrolled in Hennepin Healthcare study

Brittany Buckley woke up with a tube in her throat and a lot of questions.

She remembered the alcohol and the officers in her apartment, but somehow an entire day had passed since then. Now she was restrained to a hospital bed.

Confusion turned to anger when the hospital staff gave her a document saying they'd enrolled her in a study for a sedative called ketamine: "You are receiving this form because you or someone you care for was included in a research study examining patients with agitation."

"This is all I got," she said. "Just this form saying that I'm part of their little test."

Hennepin Healthcare has been conducting studies for years on ketamine, a powerful sedative that the hospital's leadership says can be vital when paramedics respond to calls of severely agitated or aggressive people. The current study, which began last August, requires no consent from patients whose data can be used for research, but gives the subject the option to opt out afterward.

The role of police allegedly encouraging or directing the use of ketamine by paramedics has generated outrage among community members and elected officials, since the Star Tribune reported earlier this month on a draft report by city police oversight staff. On Friday, Mayor Jacob Frey appointed former Acting U.S. Attorney General Sally Yates to lead an independent investigation into whether police went too far.

The draft report also raises questions about the role of the ketamine study in decisions about emergency treatment. Body camera footage from one case showed a woman, after being Maced by police, asking for an asthma pump, the draft report said.

Instead, a paramedic gave her an injection of ketamine.

"If she was having an asthma attack, giving ketamine actually helps patients and we're doing a study for agitation anyway so I had to give her ketamine," the unnamed paramedic told a police officer, according to the report.

After receiving ketamine, the woman's breathing stopped, and medical staff resuscitated her, according to the report. "It is troubling that the dictate of the 'study' mentioned by the paramedics appears to have played a significant role in the decision to administer ketamine," the report's authors wrote.

Hennepin Healthcare has defended the drug as medically necessary and denied that the study encourages its use, but also commissioned an independent report on whether its emergency responders acted properly.

Dr. William Heegaard, chief medical officer for Hennepin Healthcare, said ketamine can be a lifesaving tool when paramedics encounter people showing signs of "excited delirium," a condition when severe agitation can lead to death.

In an interview Friday, doctors from Hennepin Healthcare said the hospital has been studying agitation treatment since the 1980s. The current study aims to collect data on drugs they're already using to determine which are the most effective, they said.

"We've all seen agitated and confused people just die, and we're certain we can prevent that," said Dr. James Miner, chief of emergency medicine at Hennepin Healthcare. "We want to do it the best way possible."

For Buckley, it started with a relapse.

The 29-year-old said she was struggling with the anniversary of her father's death, and spent a day last December drinking wine. Her sponsor at Alcoholics Anonymous called a friend, who contacted 911 for a welfare check.

Police and paramedics came to her apartment in northeast Minneapolis. Her friend let the police into the apartment, and officers carried her to the ambulance. Buckley acknowledges she was very drunk and uncooperative when they told her she must leave in an ambulance, which she feared she could not afford. But she questions whether paramedics needed to restrain and then sedate her.

On a scale the hospital uses to judge a person's agitation levels, a "plus-four" means "severely agitated." Buckley was a "plus-two," according to her medical records, which she shared with the Star Tribune. Paramedics noted that she appeared "agitated" and "anxious" but was attentive and smiling.

The report states they opted to "enroll her in the ketamine trials." Within two minutes of injection, the drug took hold, according to medical records. In four minutes, she had trouble breathing. Paramedics put her on oxygen on the way to the hospital.

Respiratory problems appear to be common when ketamine is used on agitated patients, according to Hennepin Healthcare's published research on the drug. Doctors at Hennepin contend the agitation, not the sedative, may contribute to the complications.

In a recent paper published by the hospital, 57 percent of study patients given ketamine required intubation — inserting a tube in the throat to help deliver oxygen. In a separate paper, which compared ketamine to another sedative, haloperidol, the hospital noted that 39 percent of subjects given ketamine needed intubation, compared to 4 percent with haloperidol.

The studies are approved by institutional review boards and do not require pre-consent because they are performed in emergency situations, according to the hospital.

The findings are troubling, said Carl Elliott, a bioethics professor at the University of Minnesota. After reviewing the study protocols and past research, Elliott questioned why the hospital would continue using the drug so routinely, especially when paramedics identify the person as not severely agitated — or not a "plus-four" on the scale.

"If I were asked to consent to this study in advance, I would refuse," Elliott said. "I would never want to be in this study. And yet they're describing it to people like it's so uncontroversial that they can enroll them without even asking them."

Miner of Hennepin Healthcare said the study doesn't influence what treatment paramedics give to patients.

People in situations of extreme agitation build up dangerous levels of body acid, called acidosis, Miner said. "They just keep ramping up until we do something about it," he said.

This can continue to occur when someone is physically restrained, so it's common for paramedics at Hennepin to sedate a person who is already restrained, said Dr. Jon Cole, emergency physician and toxicologist at Hennepin Healthcare. "To us, restraints without a sedative is really bad medical care," Cole said.

Ketamine is one of a few options the hospital uses in these situations. While some drugs take more than 15 minutes to work, sedatives like ketamine and Versed — the other drug the hospital is studying — take effect almost immediately, Cole said.

Cole said using the drug to sedate a person who is not at the top of the agitation scale may still be appropriate if the paramedic fears agitation is still rising.

Cole and Miner both emphasized that paramedics are not instructed to use the drug more frequently because of the study.

"Frankly, it's a big concern of ours," said Cole. "Anytime that we interact with EMS about this, we emphasize to them, crystal clear: In no way is the study ever to increase the number of sedations. We want to observe normal, usual sedation practices."

But those who wake up to find they've been given ketamine, a drug known to cause memory loss, and enrolled in the study, say it has added more confusion to already-traumatic situations.

Katie Hosley called 911 when she found her 18-year-old son, Thomas, having a seizure in his room last October. Her son's friend said he'd taken a synthetic drug. Police and paramedics arrived at her south Minneapolis house.

"My son was, and I'm being completely honest, he was not combative at all," Hosley said. "He was not arguing. All he was doing was crying for me, because they wouldn't let me be by him."

Hosley said her son was restrained and brought to an ambulance. She raced to Hennepin Healthcare and arrived to find him unconscious and intubated, she said.

When her son was ready to come home the next day, someone handed Hosley a letter saying he'd been enrolled in a study on ketamine, a drug she'd never heard of.

"I didn't know they could do that," she said.

Andy Mannix • 612-673-4036