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Incorrect use of reversal agent during sedation

24 September 2018

An anxious patient needed extraction of LL6, which was deemed to be un-restorable by the treating general dental practitioner. The patient was subsequently referred to the local hospital for treatment. Various treatment modalities were discussed, including the option of LA only or sedation with LA. The patient, who had undergone previous extractions with LA, opted for sedation with LA, as he was aware that it would be a surgical removal and likely to be a more lengthy process.

The patient attended for the treatment at the dental hospital where he was referred and the treatment was to be completed by a consultant oral surgeon. The patient was greeted by a trained dental nurse, who checked the presence of a suitable escort. Also present was a trainee nurse, who at the time was observing the trained nurse.

The patient was brought into the oral surgery clinic and, whilst the patient was getting seated, the oral surgeon drew up the midazolam. The procedure started and it soon became apparent after titration of 20mg of the drug that the patient was not sedating appropriately. The patient was questioned on drug use, which was denied. The trained nurse then noticed that flumazenil, which is the reversal agent, had been given rather than the midazolam. The two drugs had been placed side by side and both had orange and white labels on the ampoules.

The surgeon, realising the mistake, then administered the midazolam; however, the patient did not sedate and so nitrous oxide was administered. The extraction was completed with the patient fully aware and uncomfortable throughout the procedure.

After completion of treatment the patient was taken to recovery. However, he was not advised of the incident and was monitored for only 20 minutes without being warned of the risk of rebound sedation.

The surgeon completed an incident form one week later, but did not clearly explain that after giving the patient flumazenil, midazolam was then given.

His employers were advised of the incident form and after reviewing what had taken place, they decided to carry out a full investigation, and interviewed the surgeon in question. Despite the patient not having any untoward reaction after treatment, the surgeon was criticised for not informing the patient of the incident. He was also not honest when completing the incident form. The hospital guidelines outlined that when drawing up medication it should be checked and witnessed by a second appropriate person, prior to the patient entering the room, which had not been done. Furthermore, the patient had not provided consent for the provision of nitrous oxide.

It is clear that in this case, the oral surgeon failed to adhere to the responsibilities and requirements for treating a patient under sedation. After being made aware of his vulnerabilities in terms of how he managed the incident he carried out audits on his practice and worked with his employers to put together a protocol to ensure a similar situation did not occur again. The surgeon was a member of Dental Protection and, as part of a review of his practice, he contacted us for advice.

The patient made a formal complaint and the surgeon co-operated fully with his employers in their management of the subsequent complaint. The patient accepted the hospital’s apology and the case was closed.


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