Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

4. Mrs K complains the Trust failed to provide care and treatment to her mother Mrs E between 22 September 2023 and 5 October 2023. She says the Trust:

• did not provide her mother with adequate pain management • gave her mother too much oxycodone medication.

5. Mrs K says that without the appropriate pain relieving medication her mother was in constant severe pain. Her mother was given too much oxycodone and required reversal medication. This medication caused extreme internal discomfort, led to her screaming in pain and her health to rapidly decline.

6. To resolve her complaint, Mrs K would like an apology, service improvements and a financial remedy.

7. Mrs E was diagnosed with kidney cancer in 2021. In June 2023, treatment for the cancer was no longer working and the cancer had spread to her spine causing a fracture of her spinal cord and paralysis.

8. She was admitted to the Trust and referred to the Palliative Care Team (PCT) for specialist advice on pain management. During her admission, the clinical team used a combination of treatments to manage her symptoms.

9. The PCT reviewed her regularly and she was prescribed medications including oxycodone which were adjusted frequently in response to her changing pain levels.

10. On the evening of 1 October, Mrs E’s condition deteriorated and she had difficulty breathing. The clinical team administered medication, after which her breathing improved and her respiratory rate increased.

14. Mrs E was admitted to the Trust on 22 September 2023 with very complex and severe pain related to her kidney cancer. The cancer had spread to her spine, which caused significant pain and paralysis.

15. The clinical team approached this with a combination of treatments aimed at addressing different aspects of her pain. She received regular paracetamol at the maximum recommended daily dose, alongside opioid-based analgesics including oxycodone given both regularly and as needed for breakthrough pain. Fentanyl was later introduced for additional relief during movement. Medications such as amitriptyline and pregabalin were also prescribed to target the neuropathic (nerve-related) component of her pain, and dexamethasone, a type of steroid was being used to help reduce inflammation and pressure on the spinal cord.

16. From the time of her admission, she was referred to the PCT for support with pain control. Mrs E also had other treatments, including radiotherapy and steroid treatment to help manage her pain. The effects of these treatments can take time to develop, and as a result, her pain levels may have fluctuated.

17. The Trust says that Mrs E’s pain was neuropathic and not a simple joint or muscle pain. Neuropathic pain occurs because there is a pressure on the nerves. This causes very severe pain which can escalate within a few minutes. Treating patients with this kind of pain can be very challenging.

18. Our Consultant Adviser told us that the Trust correctly identified that part of Mrs E’s pain was neuropathic. Both our Consultant and Pharmacist Advisers agree this type of pain is notoriously difficult to treat, with many of the usual medicines only being partially effective.

19. Our Pharmacist Adviser also told us neuropathic pain, which comes in flares rather than remaining constant, can be very difficult to manage. Because of this, in patients like Mrs E, there will likely be periods where achieving consistent pain control is not possible. The aim is to find a balance where regular dosing keeps pain under control most of the time, reducing the need for additional breakthrough doses. To achieve this, opioid doses are often increased as long as the patient is tolerating the medication.

20. As neuropathic pain is particularly challenging to manage, opioids and paracetamol are often not sufficient on their own. Medications such as amitriptyline and pregabalin are therefore commonly prescribed. However, unlike traditional analgesics, these medications act gradually, and may take time to achieve their full therapeutic effect.

21. To manage her pain, on 22 September, the clinical team prescribed Mrs E 10mg of amitriptyline at night and 5mg of oxycodone PRN to be taken every two hours as needed for pain management. On 23 September, she was also prescribed 20mg of regular oxycodone to be taken twice a day.

22. The PCT assessed Mrs E on 26 September and recommended increasing her regular oxycodone dosage to 30mg twice daily and to encourage the use of oxycodone PRN for breakthrough pain. They also advised increasing amitriptyline to 20mg for pain control.

23. The PCT further reviewed Mrs E on 28 September to gain a better understanding of her pain and the pattern of her medication use. Mrs E described the pain as a constant dull ache with episodes of sharp, intense pain down her spine. She reported that she was never without pain, although the intensity varied. She said the oxycodone helped to numb the pain if she was quickly given PRN as and when required dose as close as possible to the prescribed two hour interval.

24. The PCT assessed that her pain was more neuropathic in nature and was not responding adequately to increasing doses of regular oxycodone, even with the additional PRN doses and agreed to monitor her usage.

25. Our Nursing Adviser told us that there were times, particularly between 23 and 28 September, when Mrs E needed extra doses of PRN more often, indicating that her pain was harder to control during these periods.

26. On 29 September, the PCT recommended 50mg of pregabalin twice daily to optimise the management of Mrs E’s neuropathic pain.

27. Our Pharmacist Adviser told us that fluctuations in Mrs E’s pain control were not unexpected given the nature of her condition, particularly as amitriptyline and pregabalin would not yet have reached their full therapeutic effect.

28. NICE guidelines CG138 states that when a patient is unable to manage their own pain relief, nursing staff should regularly assess pain using a recognised pain scale, and provide and adjust analgesia as required.

29. The records show that Mrs E’s pain was regularly assessed. Her scores demonstrated fluctuating pain levels, with periods of adequate control interspersed with episodes of increased pain severity. The medication administration charts show that Mrs E’s analgesia was adjusted in response to her reported pain, in accordance with NICE guideline CG138.

30. Our Nursing Adviser told us that Mrs E’s medication charts show her pain relief was carefully adjusted throughout her admission in response to her needs and her care was regularly reviewed by both the PCT and oncology teams and specialists were involved in managing her pain.

31. In response to these changes in her pain, her analgesia was reviewed and adjusted appropriately. On 28 and 29 September, after her regular oxycodone dose was increased to 30mg twice daily, Mrs E required only one additional PRN dose on each day, suggesting improved pain control at that time.

32. It is recognised that there may have been occasions where there was a delay between Mrs E reporting pain and the administration of PRN oxycodone. Her pain management was complex, with fluctuating pain levels and variable response to treatment. Despite this, we have seen that PRN medication was administered by the nursing team in response to her pain.

33. By 1 October, her pain had escalated and she required two additional PRN doses in the morning. We recognise that the increase in Mrs E’s pain would have been distressing for Mrs K and her family to witness.

34. The PCT reviewed Mrs E and increased her regular oxycodone to 40mg twice daily and her PRN oxycodone dose was increased to 10mg in response to her worsening pain. In addition, 100mcg of fentanyl was prescribed to support ongoing pain management. BNF guidelines state that fentanyl can be administered for breakthrough pain in patients with chronic cancer who are on regular strong opioids.

35. Our Pharmacist Adviser told us the approach to optimising Mrs E’s oxycodone dose was appropriate, with dose titrations undertaken in accordance with the principles outlined in BNF guidelines. The BNF supports the use of regular opioids for pain alongside PRN when needed opioids for breakthrough pain, with dose titration guided by the patient’s analgesic requirements and response to treatment.

36. Mrs E’s pain levels were regularly monitored and her analgesia was adjusted in response to her changing clinical needs, in accordance with NICE guideline CG138. We have seen no evidence of service failure.

37. On the evening of 1 October, Mrs E showed signs of clinical deterioration. She had a low respiratory rate of 3 breaths per minute, a high oxygen requirement and reduced consciousness.

38. Mrs E was reviewed by a doctor at 11.01pm, who concluded that she was experiencing opioid toxicity, and prescribed naloxone hydrochloride to counteract the opioid effects. Our Pharmacist Adviser told us it is possible that the administration of naloxone would have caused breakthrough pain as it reverses the analgesic effects of the oxycodone and this could have caused Mrs E severe pain and distress.

39. We recognise that the administration of naloxone may have contributed to breakthrough pain by reversing some of the analgesic effects of the oxycodone, which may have caused Mrs E pain and distress and acknowledge the impact this may have had.

40. Mrs E’s pain was difficult to manage and fluctuated during her care, highlighting the clinical challenge of achieving effective pain control while balancing the risks associated with opioid medication. She was monitored throughout the night and following several doses of naloxone, her respiratory rate improved.

41. Our Pharmacist Adviser told us the fact that Mrs E’s respiration rate increased so quickly after the administration of naloxone that she was probably given too much oxycodone and as a consequence her respiration rate dropped to 3 to 4 breaths per minute. However, there are reports that pregabalin, although used here at a relatively low dose, has also been linked in rare cases to respiratory depression, particularly when combined with opioids.

42. The appropriate increase in Mrs E’s regular daily dose of 30mg of oxycodone to 40mg twice daily, and the fact that she was tolerating daily doses of around 80mg three or four days before requiring naloxone, indicates that this unfortunate event could not have been easily avoided and may have been a result of a rarely seen adverse effect of the combination of pregabalin and oxycodone.

43. We recognise the seriousness of a respiratory rate of 3 breaths per minute and the fact that Mrs E responded rapidly to naloxone. That said, the opioid dosing had been appropriately increased under specialist palliative care team in response to her pain management needs.

44. Our Consultant Adviser told us a flexible approach to opioid dosing is important and there is a fine balance between under prescribing and over prescribing. In this case, the prescribing of oxycodone was appropriate, however, Mrs E developed respiratory depression in the context of her underlying vulnerability and the increased opioid doses required to manage her pain.

45. Our Nursing Adviser told us that the level of her spine affected by the cancer would also have had an impact on Mrs E’s respiratory function, as pathology affecting the spinal segments can compromise the muscles involved in respiration.

46. Based on the evidence we have seen so far, whilst we recognise Mrs E more likely than not experienced opioid toxicity, this was not due to failures in prescribing. This was an outcome that was difficult to avoid in a complex patient such as Mrs E, and may have been due to a rare reaction to being prescribed both pregabalin and opioids.

47. Mrs E was reviewed again by a doctor on the morning of 2 October, by which time her vital signs had improved. The doctor recommended discontinuing her oxycodone medication pending a review by the PCT.

48. Later that day, the PCT assessed Mrs E and recommended a reduced regular dose of 10mg of oxycodone could be reintroduced if her respiratory rate was satisfactory with ongoing monitoring by the nursing team.

49. At 4pm she was further reviewed by a doctor who noted her respiratory rate was 8 to 9 breaths per minute and she had slight pain on movement. Her pain score was recorded as 5, with 4-6 indicating moderate pain. The records indicate that at 8.20pm she was given her first dose of 100mcg of fentanyl, which reduced her pain score to 0, indicating she was no longer in any pain.

50. On 4 October, the PCT assessed Mrs E. She reported feeling comfortable, with no current pain and her respiration rate was within normal limits for an adult resting range, of 12 -20 breaths per minute.

Conclusion 51. We think the Trust recognised the complexity of Mrs E’s condition and monitored her pain regularly. Her medication was adjusted appropriately in response to her changing symptoms in accordance with NICE CG138 and BNF guidelines.

52. While the episode of respiratory depression suggests that the cumulative opioid burden exceeded what Mrs E could safely tolerate, the evidence does not indicate this resulted from prescribing outside accepted practice. Rather, the doses were increased incrementally in response to severe uncontrolled pain, under specialist review and in accordance with accepted BNF guidelines.

53. We think the adverse event represented a recognised clinical risk of opioid escalation in a vulnerable patient rather than evidence that prescribing fell below acceptable standards. We do not think this amounts to service failure and we do not uphold this complaint.

54. We are grateful to Mrs K for bringing her complaint for our consideration. We understand this has been a very distressing and upsetting time. This concludes our report.

1. Mrs K complains about the care and treatment provided by the Trust to her mother, Mrs E, between 22 September 2023 and 5 October 2023. Mrs E very sadly died on 19 October 2023. We extend our condolences to Mrs K and her family and recognise these events continue to cause them significant distress.

2. We do not see any evidence of failings in the care provided to Mrs E. We have decided to not uphold this complaint.

3. We recognise the considerable distress Mrs K has experienced, and hope this report provides her assurance that her mother’s care aligned with the expected standards.