Sedation
18. Section 6 of the RCA’s guidance says there is a wide variation in sedation practice ranging from no sedation at all to routine use for spinal procedures. The guidance says anxious patients or those describing severe pain on injection may benefit from sedation.
19. Section 2 of the RCA’s guidance says clinicians must respect the patient’s right to make decisions about their care, and they must be given the time to do this. The guidance says clinicians should use the patient’s medical records or a consent form to record the key elements of their discussion with the patient.
20. Paragraph 51 of the GMC guidance says clinicians must use the patient’s medical records or consent form to record key elements of their discussion with the patient. Clinicians should include the information they discussed, any specific requests by the patient, any written, visual, or audio information given to the patient, and details of any decisions made.
21. Dr E says sedation was not an option available at the time in the hospital for pain procedures as there were no anaesthetists available. Dr E says they rarely use sedation for this procedure and the Trust listed Mrs U for local anaesthetic only.
22. The Trust says it does normally offer sedation for this procedure, but it can only offer sedation where there are adequate levels of staff to ensure the safety of the patient. It says at the time of Mrs U’s procedure, it was having trouble recruiting the permanent specialist staff it required to perform the procedure with sedation.
23. Dr E told the Trust in retrospect, it would have been better to not carry out the procedure on 19 November 2018, given Mrs U elected to have sedation. The Trust complaint file says Mrs U’s pre-procedure documentation said she was due to have sedation.
24. Mrs U signed a consent form before the procedure. Within the written consent form, the local anaesthetic box is ticked, but not the sedation box. There is a handwritten note on the form which says, ‘patient not having sedation after conversation with consultant.’
25. The consent form therefore indicates Mrs U signed to permit the Trust to undertake the procedure under local anaesthetic and without sedation.
26. It was not a shortfall in care to not provide sedation, Dr E was correct not to use sedation if the required staff were not available, as it would not be safe.
27. Mrs U provided written consent, which is appropriate, but the guidelines say written consent is only one part of the consent process.
28. Mrs U signed a consent form stating she would have the procedure under local anaesthetic but the records from the procedure do not show any details of the discussion Dr E had with Mrs U to obtain consent. There is no documented evidence of Mrs U’s contribution to the discussion as required by the guidelines.
29. The records from the procedure do not show Dr E discussed the option to return on a different day to have the procedure with sedation. In line with the guidelines, Dr E should have discussed this, outlined the options available to Mrs U, and documented the discussion in full.
30. We have considered our adviser’s comments, along with the relevant standards and guidelines, as well as documentation from the procedure. We found no failings in the Trust’s decision to not use sedation. However, the process by which Dr E obtained consent fell short of the requirements set out in the clinical standards and guidelines.
31. We found there was a failing in the consent process.
Impact of failings
32. Mrs U says having the procedure without sedation was painful. She says she had nausea and a headache after the procedure, and another Trust admitted her for treatment for two days.
33. Mrs U says she suffered from distress and trauma following the procedure and does not want any future facet joint injection treatments for her back pain.
34. Our adviser told us sedation does not relieve pain, but it stops patients remembering pain after the procedure. They said it is likely Mrs U does not remember the pain from previous procedures because of the sedation.
35. The pain a patient experiences after the procedure does not relate to whether they had sedation or not. Our adviser says a severe headache and nausea is not a likely consequence of having the procedure without sedation. Headache and nausea would be much more likely to occur with sedation than without.
36. We are sorry to learn Mrs U was unwell in the days after the procedure and we understand her concern that having the procedure without sedation, caused her symptoms. Having considered our adviser’s comments, we cannot link Mrs U’s symptoms of headache, nausea, and her subsequent hospital admission to the Trust’s decision not to offer sedation for the procedure.
37. Any patient receiving a painful procedure is likely to experience a degree of distress. We understand sedation does not reduce pain, but we can see it helps patients forget the pain which minimises the potential for distress following a procedure like this.
38. Mrs U missed the opportunity to have a less stressful experience during and after the procedure. This is because Dr E did not give her the option to come back another day (when sedation would be available) when asking her to provide consent to the procedure.
39. Mrs U received the same procedure on two earlier occasions with sedation and did not experience distress during or afterwards. On the balance of probabilities, Dr E could have prevented the distress Mrs U experienced by offering her an alternative appointment when sedation was available.
40. We found a failing in the process Dr E followed to obtain consent from Mrs U, which led to short term distress during the procedure and in the days that followed.
41. The Trust apologised to Mrs U in its response to her complaint. We do not think the Trust’s apology goes far enough to put right the impact the failing had on Mrs U.