Source · Prevention of Future Deaths

Antonio Galisi-Swallow

Ref: 2025-0608 Date: 4 Dec 2025 Coroner: Oliver Longstaff Area: West Yorkshire Eastern 3 responses identified · 3 indexed addressees View PDF

AI-generated concerns summaryThe coroner noted an absence of national guidance concerning the use of propofol for short-term sedation in children and young people on Paediatric Intensive Care Units.

Date 4 Dec 2025
56-day deadline 29 Jan 2026 est. estimated from the report date
Responses identified 3 of 3
Child Death (from 2015)

Coroner's concerns

AI summary
The coroner noted an absence of national guidance concerning the use of propofol for short-term sedation in children and young people on Paediatric Intensive Care Units.
View full coroner's concerns
During the inquest, the court was told that there is no national guidance for the use of propofol for short term sedation in children and young people on PICU’s. Following Antonio’s death, the Leeds Teaching Hospitals Trust has devised and implemented a “Guideline of the use of propofol for short term sedation in children and young people on PICU (by consultant approval only)”. The consultant paediatric intensivist who appeared at the inquest as an independent expert witness wholeheartedly endorsed that document, and opined that, had its provisions been in place in October 2021, it is likely that Antonio would not have died when he did. A copy of that document is attached. As a coroner making a report of this nature, it is not for me to recommend to any third party that the document developed by the Leeds Teaching Hospitals Trust, or any document like it, should be either more widely disseminated or adopted as official guidance.

Responses

3 respondents

National Institute for Health and Care Excellence

Other
Letter dated 14 Jan 2026 PDF
AI-classified response stance Noted
AI-generated response summary

• The National Institute for Health and Care Excellence stated it is not the appropriate organisation to develop national guidance on propofol for short-term sedation in children and young people in paediatric intensive care units. • It noted that propofol's summary of product characteristics includes a specific contraindication for sedation in patients 16 years or younger in intensive care. • It suggested NHS England or the Paediatric Critical Care Society could consider the development of local protocols for propofol use in paediatric intensive care units.

View full response
Dear Mr Oliver

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.

Paediatric Critical Care Society

PDF
AI-classified response stance Action Taken
AI-generated response summary

• PCCS informed its members of the risk of Propofol-Related Infusion Syndrome (PRIS) and emphasised the need for local guidance on propofol use. • PCCS is producing a joint position statement on propofol use in paediatric critical care, with publication expected in Summer 2026. • PCCS will introduce a mandatory minimum standard for local propofol use guidelines in Level 3 paediatric critical care units as part of its Quality Standards update.

View full response
Dear Mr Longstaff, Re: Regulation 28 Report – Death of Antonio Galisi-Swallow Thank you for your report dated 29 January 2026. On behalf of the Paediatric Critical Care Society (PCCS), I wish to acknowledge the concerns you have raised and to outline the actions we are taking to reduce the risk of future deaths. We have liaised closely with NHS England colleagues regarding the actions required in response the Reg28 report. Below are the PCCS actions we have agreed to undertake.
1. Communication to PCCS Members We have informed all PCCS members—over 1300 multidisciplinary professionals across the UK—of the risk of Propofol-Related Infusion Syndrome (PRIS). In this communication, we highlighted the issues raised in your report and referenced the case. We also emphasised the need for every paediatric critical care unit to maintain local guidance for the use of propofol in PCC. This communication was disseminated in February 2026.
2. Joint Position Statement PCCS has convened a specialist group including paediatric intensivists, anaesthetists and pharmacists, with representation from PCCS, the Association of Paediatric Anaesthetists (APA) and the Neonatal and Paediatric Pharmacists Group (NPPG). This group is producing a joint position statement on the use of propofol in paediatric critical care. We expect to publish this on our respective websites in the Summer of 2026.
3. Revision of PCCS Quality Standards As part of the scheduled update to the PCCS Quality Standards (Version 7), we will introduce a mandatory minimum standard requiring all Level 3 paediatric critical care units to have an agreed local guideline for propofol use. This revision will be published later this year. We are committed to supporting safe sedation practice across paediatric critical care and believe the actions above represent meaningful steps to address the concerns identified in your report. Please let me know if further information would assist your consideration. On behalf of PCCS,

[Page 2]

NHS England

NHS / Health Body
Letter dated 23 Mar 2026 PDF
AI-classified response stance Action Taken
AI-generated response summary

• The PCCS communications team shared a President's message with all PCCS members referencing the Regulation 28 Report and the risk of propofol infusion syndrome in PICUs. • PCCS will produce a position statement on the use of propofol in Paediatric Intensive Care in collaboration with the National Paediatric Pharmacy Group and the Association of Paediatric Anaesthetists. • The next iteration of PCCS standards will include a specific requirement for all PCC units to have a local guideline for the use of propofol in PICU.

View full response
Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Antonio Galisi-Swallow who died on 7th October 2021. Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 29th January 2026 concerning the death of Antonio Galisi-Swallow on 7th October 2021. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Antonio’s parents and family. NHS England is keen to assure the family and yourself that the concerns raised about Antonio’s care have been listened to and reflected upon. Your Report raises concerns that there is no national guidance for the use of propofol for short term sedation in children and young people on Paediatric Intensive Care Units (PICUs). Summary of Product Characteristics (SPC) and the British National Formulary (BNF) entry for propofol do include an indication for the 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)’. We have had sight of Professor response to your Report and concur with him that the above does not mean that propofol cannot be used in clinical practice 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 prescribe, review and monitoring details, and limitations on use). NHS England commission PICU services in line with Paediatric Critical Care Society (PCCS) standards. Standard L3-505 lists clinical guidance that each PICU should have in use and these include ‘Drug administration and medicines management’ and ‘Procedural sedation and analgesia’. PICU services are responsible for developing their own local guidelines as a requirement of PCCS standards.

[Page 2] Locally developed guidance (taken through Trust governance) is mandated and is part of NHS England’s commissioning documentation as well as professional standards. Locally developed guidance allows guidance to be specific to the Trust’s PICU and the population being treated there, as there are different uses for drugs in different PICUs. For example a cardiac PICU will use different doses of drugs. In response to the Inquest touching the death of Antonio Galisi-Swallow NHS England and the PCCS will take forward the following actions:
1. The PCCS communications team has shared a "President's message" - an email bulletin to all PCCS members ( professionals actively involved in or contributing to paediatric critical care, including doctors, nurses, and allied health professionals) referencing the Regulation 28 Report and the risk of propofol infusion syndrome in PICUs. This has been completed as of February 2026.
2. PCCS will produce a position statement on the use of propofol in Paediatric Intensive Care to formally raise awareness amongst the PICU community. This will be produced in collaboration with the National Paediatric Pharmacy Group (NPPG) and the Association of Paediatric Anaesthetists (APA). This statement will be shared with all PCCS members and hosted on the PCCS website. (Expected completion date: Summer 2026).
3. The next iteration of the PCCS standards ( Version 7 is currently under development) will include a specific requirement that all PCC units must have a local guideline for the use of propofol in PICU. (Expected completion date: end of 2026) NHS England will support with the development and implementation of the actions to ensure all PICUs have appropriate arrangements in place for the safe use of propofol. Action 2 allows engagement with the relevant professional groups (anaesthetists and pharmacy) and is a formal communication to ensure units take swift action without waiting for the longer-term action of the overall standards re-write (Action 3 listed above). I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Antonio, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action. Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Report sections

Investigation and inquest
On 12/10/2021 I commenced an investigation into the death of Antonio Galisi-Swallow who died aged 15 in the Leeds General Infirmary on 7th October 2021, three weeks short of his 16th birthday. The investigation concluded at the end of the Inquest on 04/12/2025. The medical cause of death was 1a) Propofol-Related Infusion Syndrome (“PRIS”); b) Prolonged Propofol Administration Post Cardiac Surgery; 2) Trisomy 21 with Surgically-Corrected Congenital Cardiac Malformation. In summary, the narrative conclusion to the inquest was that Antonio died from the effects of receiving a continuous propofol infusion of 5634 milligrams plus additional bolus doses over a period of 121 hours, while in post-operative sedation on the Paediatric Intensive Care Unit (“PICU”).
Circumstances of the death
Antonio had Downs, ADHD and was on the Autistic Spectrum Disorder. He was born with Tetralogy of Fallot, a congenital cardiac malformation that required a series of surgical interventions. He underwent a pulmonary valve implantation procedure on 30th September 2021 to address his severe pulmonary valve regurgitation. Following surgery, Antonio was admitted to the PICU under sedation with significant ventilatory requirements related to a presumed chest infection for which he was given antibiotics, requiring mechanical ventilation for a longer period than originally intended. Antonio’s sedation was maintained from 30th September by a constant propofol infusion and occasional bolus doses, the overall rate of infusion being gradually reduced, but never stopped. From 4th October, Antonio developed a persistent and increasing fever, though his infection markers were falling. On 5th October he was noted to have a Stage 1 acute kidney injury, although his infection markers were either normal or still falling. His clinical features were consistent with a resolving chest infection, his worsening pyrexia and renal failure being likely due to another pathological process. On 6th October, concern was raised for the first time that Antonio’s deterioration might be due to PRIS. His propofol was stopped and replaced with fentanyl. Blood tests for creatine kinase, triglycerides and lactate were strongly supportive of the suggested diagnosis. By the evening of that day, Antonio was displaying what an expert witness described as almost all the classically reported features of PRIS. Tests and investigations to confirm a diagnosis continued into the early hours of 7th October, although Antonio’s parents expressed concerns that their son had been through enough and should be allowed to pass away. He went into cardiac arrest at 0337h and, despite attempts at resuscitation, was pronounced deceased at 0400h.
Action should be taken
I have been advised by Professor Jonathan Benger, Chief Executive, National Institute for Health and Care Exellence (to which organisation this report was originally sent) that your organisation is more appropriately placed to act upon it. I attach a copy of Professor Benger’s letter to me dated 14/01/2026.

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Report details

Reference
2025-0608
Date of report
4 December 2025
Coroner
Oliver Longstaff
Coroner area
West Yorkshire Eastern

Responses identified

Responses identified 3 of 3
All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 29 Jan 2026 (estimated from the report date).

Sent to

National Institute for Health and Care Excellence
Paediatric Critical Care Society
National Clinical Director for Children and Young People,

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