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A novel multipatient intranasal diamorphine spray for use in acute pain in children: pharmacovigilance data from an observational study.

Kendall, J; Maconochie, I; Wong, IC; Howard, R; DIASAFE study, A; (2015) A novel multipatient intranasal diamorphine spray for use in acute pain in children: pharmacovigilance data from an observational study. Emergency Medicine Journal , 32 (4) pp. 269-273. 10.1136/emermed-2013-203226. Green open access

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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.

Type: Article
Title: A novel multipatient intranasal diamorphine spray for use in acute pain in children: pharmacovigilance data from an observational study.
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/emermed-2013-203226
Publisher version: http://dx.doi.org/10.1136/emermed-2013-203226
Language: English
Additional information: This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/
Keywords: Acute Pain, Administration, Intranasal, Adolescent, Analgesics, Opioid, Child, Child, Preschool, Emergency Service, Hospital, England, Female, Heroin, Humans, Infant, Male, Pharmacovigilance
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Practice and Policy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Developmental Neurosciences Dept
URI: https://discovery.ucl.ac.uk/id/eprint/1423659
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