NICE declines to develop national guidance on propofol for short-term sedation in children on PICUs, stating that local protocols are more appropriate due to varying local prescribing issues. They suggest that NHS England or the Paediatric Critical Care Society could consider suggesting that all PICUs develop local protocols. (AI summary)
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Re: Regulation 28 Prevention of Future Deaths Report (Antonio Galisi- Swallow)
I write in response to your regulation 28 report dated 4 December 2025 and addressed to my predecessor , regarding the very sad death of Antonio Galisi-Swallow. I would like to express my sincere condolences to Antonio’s family.
The patient safety leads at NICE have discussed the report and understand that your request is that we develop national guidance on propofol for short term sedation in children and young people on paediatric intensive care units (PICUs).
Our conclusion is that NICE is not the appropriate organisation to develop guidance in this area, and I have explained the reasoning for this below.
The summary of product characteristics (SPC) and the British National Formulary (BNF) entry for propofol do include an indication for sedation of children under 16 years, however it is a specific contraindication in section 4.3 of the SPC: ‘Propofol must not be used in patients of 16 years of age or younger for sedation for intensive care. Safety and efficacy for these age groups have not been demonstrated (see section 4.4)’.
I would like to make it clear that we are not saying that propofol should not have been used in this situation, as many drugs are not licensed for use in children due to a lack of specific paediatric research evidence. However, use of these types of drugs should be supported by strong local protocols. Such protocols should include patient selection, contraindications, cautions, and local prescribing issues (such as who can
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prescribe, review and monitoring details, and limitations on use). As these issues will vary by locality, they are best described in local guidance. .
The Paediatric Critical Care Society Standards outline the requirements for care, and Standard L3-505 lists the clinical guideline that each PICU should have; these include ‘Drug administration and medicines management’ and ‘Procedural sedation and analgesia’. We would expect guidance on the use of propofol to be included in this.
Our view is that this issue would be best addresses by NHS England or the Paediatric Critical Care Society (PCCS) who could consider the suggestion that all PICUs develop local protocols such as the one used in Leeds. The following contacts may be useful to you for this purpose:
• NHS England’s national clinical director for children and young people, Professor
• PCCS via
I hope that the information above is helpful and would like to reiterate my sincere condolences to Antonio’s family.