We’re told that serious illness in Covid-19 presents pneumonia and accompanying respiratory insufficiency. Therefore typical symptoms include breathlessness, cough, weakness and fever. We’re also told that people who suffer deteriorating respiratory failure and who do not receive intensive care, develop acute respiratory distress syndrome with severe breathlessness.
Intravenous midazolam hydrochloride is associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. When this was not recognised promptly and treated effectively, death or hypoxic encephalopathy can follow.
Knowing that would you use midazolam to treat people who were suffering with pneumonia and respiratory insufficiency allegedly due to Covid-19?
Our observations of the apparent effects of the sedative midazolam on our fathers, who both died from cancer a week apart in October 2018, have left us with some questions.
Midazolam is a powerful benzodiazepine drug, very widely used in a variety of medical applications. Although midazolam has no analgesic properties, it was repeatedly described to us as a “breakthrough drug”, implying that it was being used to suppress spikes in pain above the level the prescribed doses of painkillers could handle. We believe this terminology is highly misleading.
We ask if this drug is being administered carefully enough, with enough consultation, and with enough consideration of possible negative effects.
I apologise in advance if these questions offend some doctors and nurses, or make other people uncomfortable. We realise the market for this drug is huge and we are not attempting to interfere with a highly profitable business. All we want to do is describe our experiences and respectfully ask our questions.
Significantly, it appears that the prescription of midazolam has spiked during the COVID-19 pandemic, leading to allegations in the press that the drug is being used to “control elderly patients in stretched care homes – or even to hasten their deaths”.
According to one recent article in the UK Daily Mail, whistleblowers have claimed they were told to administer the drug to stop confused patients wandering. The article also reports that: “Retired neurologist Professor Patrick Pullicino, who was instrumental in raising concerns a decade ago that the Liverpool Care Pathway was bringing forward patients’ deaths, believes the jump indicated something similar had happened. He said: ‘Midazolam depresses respiration and it hastens death. It changes end-of-life care into euthanasia.’”
This assertion has been disputed. However, it has been reported that the 2015 death in custody of indigenous man David Dungay, whose fate has largely driven some of Australia’s Black Lives Matter protests, stopped breathing and died after being injected with midazolam after refusing an order to stop eating biscuits.
What we have seen has led us to question the use of this powerful drug.
About a week before my father died in a private hospital from aggressive cancer, he complained that he had been administered a “nightmare drug”.
He said nursing staff had told him they were trying something new with his medication, a “breakthrough medicine”, but it hadn’t worked and he was told he had experienced a bad reaction.
The “nightmare drug”, he said, had robbed him of any power over his body. He was quite traumatized while telling us about it, but I didn’t pay as much attention as I should have. I thought the sensations might have been caused by the interplay between his illness and the powerful painkillers he was taking. I’ve sometimes had dreams in which I experienced the kind of disconnect he described, so I thought perhaps that might have explained it.
Dad said the worst effect of the drug was that he was unable to tell the nursing staff he was in pain. He had become used to telling them when the pain level rose above the capacity of the morphine he was on, and we had become familiar with the term “breakthrough drug” to refer to top-ups of painkiller. Because of the “nightmare drug” he had lain for some hours unable to move or speak, but suffering serious pain until it wore off enough for him to be able to speak again.
I spoke to the nursing staff about this. They named the drug as midazolam. I was told it was used to deal with “breakthrough pain”, but clearly it didn’t work in Dad’s case. Only later did I discover that midazolam has no analgesic properties. Not only that: it may actually increase perceptions of pain.
The “nightmare drug”
Not long after this my father died, as expected. Shortly before he passed away, however, he told his doctor that he was concerned that the medication he was taking might have been making him mentally fuzzy. It was debated whether this was an effect of the medication or the illness, but Dad told us the doctor agreed to scale back his medications to see what happened. The morning after this occurred, we were told, Dad complained of worse pain and he was strongly medicated. He never regained consciousness.
Sitting by his side he scarcely seemed present at all. His breath scraped and rattled, his eyes were permanently half-closed and he never moved any part of his body except, it seemed, involuntarily. Now and then he would jerk and let out a harsh cry – as if in pain – before lapsing back into inertia.
I spoke to a nurse who told me that this was a natural stage in the process of dying. She urged us to stay, to hold Dad’s hand and talk to him because, she said, hearing was usually the last thing to go. Dad could hear and understand us, she said.
This seemed borne out by one incident when we were talking about the fate of Dad’s ashes. I said aloud that we knew already that his ashes would be kept until Mum passed away, then the ashes of both would be scattered at a previously agreed favourite place. As soon as this was said, Dad’s arm flung out towards my mother and he gave one of his harsh cries. It seemed to me that he had overcome some massive drag on his body to perform this action.
I was struck, all the while, by how different this process of dying seemed in comparison to descriptions given to me by a number of other people. They had described a process in which the dying person drifted in and out of consciousness, sometimes speaking, sometimes silent until the end came. For Dad it was not like that. Now I wonder if his ability to communicate his pain was suppressed by sedatives. I wonder if he died in pain, after all, and whether I let him down by not understanding what was happening.
Perhaps I would not have revisited this matter quite so earnestly if it was not for the death one week later of my father-in-law.
While my father lay dying in a private hospital, my wife’s father was in a similar condition in a palliative care hospice. Jakim also had cancer, a slow-growing complex of tumours clustered about the back of his tongue, throat and neck. It had taken a while, but these eventually grew enough to precipitate a crisis that caused him to be admitted to hospital, from where he was quickly transferred to the hospice.
It seems appropriate here to let my wife tell the story, with the words taken from our complaint to the hospice management.
I was well aware that my father was dying, and that his death would come soon. That was why he was in the hospice, which I had believed would be the best place for him to be.
During his first few days in the hospice Dad had a healthy appetite and was eating his meals. He was able to get himself in and out of bed into a chair and go to the bathroom by himself with the aid of his walker. He was communicating normally.
On Saturday, October 6, my brother and two of his children were the first to visit at about 12.20pm, arriving shortly after lunch was delivered. They found our father sitting in an armchair, unresponsive, with his tongue pushing out of his mouth, eyes partially open and rolled back. His lunch tray was in front of him and the food on the tray was still warm. Myself, my husband and stepmother arrived shortly after.
Unresponsive after one injection
Dad was totally unresponsive. I found a staff member – who turned out to be one of the two staff that administered the injection – and asked her what had happened to our father. This staff member was not a registered nurse. She told me that when she had checked in on Dad before we arrived, he had his head in his hands and she said she had heard him moan. She relayed this to a doctor who prescribed what the nurse referred to as a “breakthrough drug” to ease Dad’s pain. I asked her to come and see our father. When she saw him she was quite shocked. She said that she believed she had injected Dad with a pain medication and that he must have had a bad reaction to it. She said the drug should wear off in a couple of hours.
At this stage none of us, apparently including the staff member, realised the drug she had administered to our father was a powerful sedative.
We all stayed for the afternoon and throughout that time Dad was unresponsive. My brother left shortly after 5pm and at about 5.45 the dinner tray arrived. I managed to rouse my father and told him that his dinner had arrived and asked him if he was hungry. He said he was, so I assisted him out of bed and into the armchair. He attempted to feed himself with no success. He was unable to use his arms to bring his food to his mouth. Each time he tried his arms failed him and would drop. I had to assist him. Without assistance Dad would not have been able to feed himself. With my help he ate everything on his tray.
We learned that the drug administered was midazolam, and we recognized this as the drug that Greg’s father had described just the week before as a “nightmare drug” that had prevented him from moving or communicating.
We looked up midazolam on the web and discovered it had been highly controversial in the USA where it has often been used on death-row prisoners to create the impression that their execution is not painful. It seems apparent from much that has been written that this impression may not be accurate and that the drug might merely tend to prevent prisoners from expressing their pain – although it is evidently not always successful even in this.
By Sunday, October 7, Dad had recovered markedly but was still very disoriented. He asked what day it was and where he was. He managed to eat his lunch mostly unassisted but needed a bit of help towards the end. That afternoon two of my brothers and a number of other family members visited. After taking Dad outside for a short walk in a wheelchair – as he felt too weak to walk – my brothers and I played cards with him. He also ate all his evening meal. Before we left for the evening Dad went to the bathroom by himself with only the walking aid to assist him. We made sure he was settled in bed before we left for the night.
Fell out of bed: midazolam again
The following morning, Monday, October 8, I had a call at 6.30am from one of the nurses at the hospice informing me that Dad had fallen during the night. He had been found at 4am and was now unresponsive, she said. She asked if I could come in at around 8am. I left for the hospital straight away and got there by 6.50am.
I was met by a nurse outside my father’s room. I asked her what had happened. She told me that in the night she had observed my father sitting up in bed about midnight, heard him moan and thought he was in pain so she had given him a shot of methadone. I asked her if she had given my father midazolam. She told me she had. When I asked her what time she administered midazolam, she told me it had been shortly after the methadone was given, at about 12.30am. She had given midazolam because she felt the methadone had not eased his pain and he was still attempting to sit up.
My father was found on the floor at 4 am in a puddle of urine with the urine bottle he used at night beside him. It is clear to me my father needed to empty his bladder and when he attempted to do this he collapsed.
[The nurse did not tell me she had also given him another two injections of midazolam, one at 4am when he was found on the floor and another at 6.20am – only 10 minutes before she called me. Her call, ostensibly, was to inform me that my father had fallen and was unresponsive. She told me this in a way that suggested she had no idea why he was not responding. Clearly, if she had administered midazolam, his unresponsiveness was to have been expected.]
In a conversation later that morning with the doctor overseeing Dad’s treatment, I expressed concern about midazolam. The doctor insisted that Dad’s condition was in no way due to medication but to the cancer. I again expressed my concern about the use of midazolam and told her that I no longer wanted it to be administered to my father. She insisted that midazolam wears off over a couple of hours and refused to stop it completely but agreed to decrease the dose from 2.5mg to 1mg. She told me I had to accept that my father was dying.
She then told me that Dad was given midazolam because he was distressed. She said the nurse who had found him on the floor believed he was so distressed because he was extremely constipated, and that because of this he had been unable to empty his bladder fully. (It later emerged that he had been given no anti-constipation medication during his entire stay to that point, despite being on high doses of opiates which are known to interfere with bowel function.)
Throughout the day Dad remained unresponsive. He couldn’t drink or eat anything. By now he had been given an injection and suppositories for the constipation. At one point he awoke and became quite distressed and insisted on going to the bathroom to use his bowels. With the assistance of a nurse we managed to get Dad onto a mobile commode chair and wheeled him into the bathroom. He again became unconscious so I buzzed for a nurse, and with great difficulty both of us managed to get my father back into bed.
Attempting to communicate
In the evening Dad was attempting to communicate but we could not understand anything he was trying to say. He would double up in pain from what looked to be stomach cramping. I stayed with Dad all that night.
I was quite baffled as to why my father was still uncommunicative. Our research of midazolam had indicated that one dose of the drug at 12.30am should have worn off by this time. Late that evening while I was talking to one of my sisters-in-law in the corridor, two nurses came to check on Dad. They had his chart so I asked them what time the last injection of midazolam had been administered. They told us the most recent injection had been administered at 6.20am. I was shocked to learn this. I asked them what time the earlier injection of the drug had been given and they told us Dad had been given a dose at 12.30 and then another at 4am. So he had been given three injections in a six hour period. It was no wonder Dad was uncommunicative. On learning this we decided not to leave Dad unattended, so my stepmother and I stayed and supervised him during the night.
Next day we had a family meeting with hospice staff at which we tried to get an undertaking that midozalam would not be administered again. Unfortunately, the atmosphere at the meeting felt very hostile to us, especially when we asked to be consulted about the medications being used in Dad’s care. When we described our observations of the results of the administration of midazolam we were told that we were wrong. It was not midazolam that caused these effects, but the illness itself, we were told. We were criticized as a family for not being sufficiently trusting of the hospice.
My father remained in a state of delirium the rest of the day. He was unable to eat anything and was only able to take small amounts of water we dropped into his mouth with the use of a straw. I remained with him for the following two nights and my brother and other family members stayed with him during the days. His sleep was fitful. When he tried to communicate I could understand words he was saying but they didn’t make much sense.
The following day Dad started to communicate a bit more. He asked for something to eat and my brother gave him a tub of custard which he ate half of. I returned in the afternoon and stayed for a third night. By the evening he was more communicative. He begged me not to leave him because he was scared he would fall again. He told me he was thirsty and I asked a nurse if there was thickened water as he was still unable to handle water well. The nurse brought me a tub which my father ate rapidly. Over the next hour he consumed another four and a half jars of thickened water. Throughout the night my father was finally starting to recover. He asked me for water when he was thirsty and at one time he even wanted to watch TV. During the night, the pump that administers the pain medication needed to be replaced.
Next morning, as an inquiry into Dad’s fall got underway and as we awaited the changeover in care personnel we had requested, he was given an injection which the person administering told us was a steroid.
Dad died about 1pm.
We made a formal complaint to the hospice, specifically criticizing the failure to prescribe constipation medication. We asserted our belief that midazolam was administered at inappropriate times, in inappropriate doses and with inadequate medical oversight. We complained of misleading communications from staff and we complained of what we believed was a hostile and combative reaction to our initial concerns.
The organisation responsible for the hospice apologised that the failure to administer anti-constipation medicine was “an oversight”.
We were advised that midazolam was administered four times and we were told that nurses were legally permitted to administer “breakthrough medication” without a doctor observing first-hand. The letter also stated that the doses given were within prescribing guidelines and were in fact half of the recommended maximum daily dose.
Despite this letter again referring to midazolam as a “breakthrough medication”, the next page of the same letter stated that: “I apologise that you were informed that Midazolam was administered for pain, this is incorrect. Midazolam is administered in the last days of life to manage breathlessness, restlessness, agitation and anxiety”.
We received an apology for misleading information given by a hospice staff member and we were promised that the organisation would “ensure that all palliative care nursing staff are adequately trained in open disclosure and NSW Health Education module “Partnering with Carers”.
A pharmacologist’s opinion
Experiencing two deaths in the family in the course of a single week was traumatic, and it might be thought that this – coupled with the bad experience in the hospice – could have clouded our judgement and made us paranoid.
I was concerned about this too. I was worried that our doubts about midazolam and its use might be a product of an over-wrought emotional frame of mind. Certainly, what I had read about the drug in the context of death-row prisoners seemed a long way from its application in palliative care, and I would have liked to have received credible reassurance that my fears were misplaced.
But the more we read, the more we feared that midazolam, by rendering patients inert and uncommunicative, might even hasten death without reducing suffering. We believe it can reduce the ability of patients to communicate important facts about their pain and other aspects of their condition. We believe it is misleading to assert that the inert state which can be induced by doses of Midazolam, is a natural part of the process of dying.
Nurses and doctors directly involved in these cases and in facilities where the drug is often used were anxious to assure me that midazolam is a “breakthrough drug” used to quash pain that spikes above the opiate painkillers. When I observed that this was not a very accurate picture to paint, since it is known and accepted worldwide that the drug has zero analgesic properties, they said it was used along with painkillers to alleviate distress. In particular the distress that comes with approaching death.
I didn’t feel reassured so I turned to a person I knew and respected from my years as health reporter with The Newcastle Herald.
Professor David Henry is a clinical pharmacologist with a worldwide reputation. I had interviewed him often in a professional capacity and I knew him to be honest, compassionate and ethical.
After a short search I located him at Bond University in Queensland, and told him our stories. I asked him whether I was barking up the wrong tree by harbouring concerns about the use of midazolam in the palliative care setting. I honestly hoped he would convince me I was wrong to be concerned.
Asking hard questions
Instead he said he knew exactly what I was talking about and he told me that he had personally insisted that no such sedatives be used on his mother when she was dying. He encouraged me to ask the hard questions and to ask them publicly.
Professor Henry shared a couple of items from medical journals that he thought I might find interesting. The first, a letter published in the Journal of Palliative Medicine in 2015, notes that midazolam is indeed a very prolifically administered drug in Australian palliative care practice. Author Dr Katherine Clark noted in the letter that “the evidence that supports the benefits and harms associated with the frequent use of this medication remains less than robust” and concludes that “if there is a real commitment to providing patient-centred care at the end of life, the costs to the population of regularly prescribing midazolam must be investigated further.”
A second item shared by Professor Henry was an article in the journal Anesthesiology, in March 2013, by Michael Frolich, Kui Zhang and Timothy Ness of the University of Alabama. This article reported evidence that midazolam actually increased the acuity of perception of cold, heat and pain, “contrary to the belief of many clinicians that sedative drugs will reduce pain perception”. The paper goes on to describe the belief on the part of many practitioners that adding a sedative like midazolam is a solution when pain relief medications aren’t quite achieving the desired level of relief. It suggests this belief is mistaken. Our personal experiences would lead us to agree.
Even the Wikipedia entry for midazolam states that the drug should be used with “additional caution in the elderly as they are more sensitive to the pharmacological effects of benzodiazepines, metabolise them more slowly, and are more prone to adverse effects, including drowsiness, amnesia (especially anterograde amnesia), ataxia, hangover effects, confusion, and falls”. Also: “Additional caution is required in critically ill patients, as accumulation of midazolam and its active metabolites may occur. Kidney or liver impairments may slow down the elimination of midazolam leading to prolonged and enhanced effects.”
A number of people we have spoken to informally about our experiences have described similar situations and we believe a widespread and serious issue may exist.
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