DIASAFE STUDY Version 1.0

• Research type

  Research Study

• Full title

  An open label, single dose safety study of Diamorphine Hydrochloride Nasal Spray (0.1mg/kg)in children

• IRAS ID

  42839

• Sponsor organisation

  Wockhardt UK Limited

• Eudract number

  2009-014982-16

• Research summary

  Diamorphine hydrochloride (a derivative of morphine) is a powerful analgesic used to treat acute pain. Strong analgesics are currently administered by oral, parenteral (intravenous or intramuscular), or rectal routes. Because these routes of administration have strong limitations, particularly in children, the aim is to develop a new formulation of diamorphine hydrochloride which will be administered as a spray via the nose, ie intranasally. The aim of the study is to investigate the safety properties of diamorphine hydrochloride nasal spray solution delivered at a dose of 0.1mg/kg in children aged 2 ?? 16 years in an emergency setting . The study will be conducted at 2 hospital sites in children who are suffering from acute pain following a suspected clinical fracture or other trauma and who, in the opinion of the attending physician, require immediate analgesia with intranasal diamorphine. After obtaining written informed consent from the parents/ legal guardians and if appropriate assent from the patient, intranasal diamorphine will be administered as part of the standard analgesic treatment in the emergency department. Vital signs, Glasgow coma score and nasal irritation will be assessed and recorded at regular intervals after administration until discharge from the emergency department. All adverse events will be recorded throughout the duration of the child's participation in the study and for 7 days post dosing. Children will receive further pain relief as required according to the normal hospital procedure. The safety profile will be assessed by adverse events categories according to the current version of MedDRA. Patients will be allowed to withdraw from the trial at any time.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  10/H0106/4

• Date of REC Opinion

  25 Feb 2010

• REC opinion

  Further Information Favourable Opinion