A novel multipatient intranasal diamorphine spray for use in acute pain in children: pharmacovigilance data from an observational study
Author(s)
Kendall, Jason
Maconochie, Ian
Wong, Ian CK
Howard, Richard
Type
Journal Article
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.
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.
Date Issued
2015-04-01
Date Acceptance
2013-11-23
Citation
Emergency Medicine Journal, 2015, 32 (4), pp.269-273
ISSN
1472-0205
Publisher
BMJ Publishing Group
Start Page
269
End Page
273
Journal / Book Title
Emergency Medicine Journal
Volume
32
Issue
4
Copyright Statement
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/
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000351691400004&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Emergency Medicine
ANALGESIA
HEROIN
Publication Status
Published
Date Publish Online
2014-01-09