title: A novel multipatient intranasal diamorphine spray for use in acute pain in children: pharmacovigilance data from an observational study.
abstract: OBJECTIVE
  To establish the safety of an intranasal diamorphine (IND) spray in children.
  
  
  METHODS
  An open-label, single-dose pharmacovigilance trial.
  
  
  METHODS
  Emergency departments in eight UK hospitals.
  
  
  METHODS
  Children aged 2-16 years with a fracture or other trauma.
  
  
  METHODS
  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.
  2009-014982-16.
authors.affiliation: Emergency Department, Frenchay Hospital, Bristol, UK.
authors.forename: Jason
authors.initials: J
authors.lastname: Kendall
authors.affiliation: Emergency Department, St Mary's Hospital, London, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Maconochie
authors.affiliation: Therakind Ltd, London, UK Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, University College London, London, UK.
authors.forename: Ian C K
authors.initials: IC
authors.lastname: Wong
authors.affiliation: Great Ormond Street Hospital, London, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Howard
mesh_terms: D059787:Acute Pain / Q000188:drug therapy*; D000281:Administration, Intranasal; D000293:Adolescent; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004636:Emergency Service, Hospital; D004739:England; D005260:Female; D003932:Heroin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007223:Infant; D008297:Male; D060735:Pharmacovigilance
chemical_list: D000701:Analgesics, Opioid; D003932:Heroin