Nasal diamorphine spray shows a good safety profile when used as an analgesic agent for acute moderate to severe pain in children presenting to the emergency department and has been subsequently licensed in the UK for acute severe pain in children.

There were no serious or severe adverse events amongst 226 children who received 0.1mg/kg intranasal diamorphine. The overall incidence of adverse events was 26.5%, 93% of which were mild. 20.4% of patients reported nasal irritation.

Introduction

Urgent pain relief is required for children presenting with fractures and burns in the emergency department (ED). Simple analgesics (eg, paracetamol) are insufficient to relieve severe pain; opiate analgesia is usually needed. Oral opiates are inappropriate due to delayed gastric emptying and slow onset of action; rapid routes of administration are necessary in the acute setting (ie, intravenous and intranasal delivery).

Diamorphine is a semisynthetic derivative of morphine that is licensed for moderate to severe acute pain, usually administered by the intramuscular or intravenous routes in the UK and Ireland. Diamorphine has properties that render it suitable for administration via the nasal route.1 First, it has good aqueous solubility, so a high dose can be given in a small volume thus avoiding swallowing excess solution which then enters the first-pass enterohepatic cycle of metabolism. Second, it is a highly lipid soluble which provides a rapid onset of action, as it crosses the blood-brain barrier more readily than morphine. Diamorphine is a prodrug of morphine which induces more rapid and more intense central nervous system effects.1 ,2

Following initial efficacy studies3 ,4 it has become common practice in the UK to administer intranasal diamorphine (IND) to children at a dose of 0.1 mg/kg to relieve acute pain in the ED.5–7 The College of Emergency Medicine and Advanced Paediatric Life Support Guidelines recommend this practice,8 ,9 and it is a treatment option in the British National Formulary for Children.10 Currently, IND is used off-label for children in approximately 55% of EDs in the UK,6 ,7 usually between 3 years and 12 years of age. Although there are randomised and open-label studies to demonstrate the efficacy of IND use in children, IND has never been licensed as a medicinal product. Consequently, systematic evaluation of safety data of IND use in children are still lacking.

We report a large formal safety study of a diamorphine hydrochloride nasal spray.