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

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 'Нет данных' 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.