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A novel multipatient intranasal diamorphine spray for use in acute pain in children: pharmacovigilance data from an observational study
  1. Jason Kendall1,
  2. Ian Maconochie2,
  3. Ian C K Wong3,4,
  4. Richard Howard5,
  5. on behalf of the DIASAFE study,
  6. Vanessa Lawlor,
  7. Hannah Skuse,
  8. Ian Gilmour,
  9. Charlotte Sykes,
  10. Dr Elizabeth Gilby,
  11. Angela Green,
  12. Kelly Davidson,
  13. Dr Tina Sajjanhar,
  14. Robert Cole,
  15. Prof Jonathan Benger,
  16. Dr Giles Haythornthwaite,
  17. Judith Edwards,
  18. Rebecca Ace,
  19. Marie Teresa-Marie Jones,
  20. Dr Cliff Mann,
  21. Sara Lees,
  22. Dr Sharryn Gardner,
  23. Zena Haslam,
  24. Moira Morrison,
  25. Anne Welling,
  26. Dr Joanna Hartley,
  27. Sarah Cooke
  1. 1Emergency Department, Frenchay Hospital, Bristol, UK
  2. 2Emergency Department, St Mary's Hospital, London, UK
  3. 3Therakind Ltd, London, UK
  4. 4Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, University College London, London, UK
  5. 5Great Ormond Street Hospital, London, UK
  1. Correspondence to Dr Jason Kendall, Emergency Department, Frenchay Hospital, Frenchay Park Road, Bristol BS16 1LE, UK; jason.kendall{at}nbt.nhs.uk

Abstract

Objectives To establish the safety of an intranasal diamorphine (IND) spray in children.

Design An open-label, single-dose pharmacovigilance trial.

Setting Emergency departments in eight UK hospitals.

Participants Children aged 2–16 years with a fracture or other trauma.

Outcome measures Adverse events (AE) specifically related to nasal irritation, respiratory and central nervous system depression.

Results 226 patients received 0.1 mg/kg IND. No serious or severe AEs occurred. The incidence of treatment-emergent AEs (TEAEs) was 26.5% (95% CI 20.9% to 32.8%), 93% being mild. 89% were related to treatment, all being known effects of the drug or route of administration except for three events in two patients. 20.4% (95% CI 15.3% to 26.2%) patients reported nasal irritation, all mild except one moderate and one ‘unknown’ severity. No respiratory depression was reported. Three AEs related to reduced Glasgow Coma Score (GCS) occurred, all mild.

Conclusions There were no safety concerns raised during the conduct of the study. In addition to expected side effects, IND can cause mild nasal irritation in a proportion of patients.

European Union Drug Regulating Authorities Clinical Trial No 2009-014982-16.

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