DIAPOP STUDY Version 1.0

• Research type

  Research Study

• Full title

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

• IRAS ID

  42133

• Sponsor organisation

  Wockhardt UK Limited

• Eudract number

  2009-014983-20

• Research summary

  Diamorphine hydrochloride (a derivative of morphine) is a powerful analgesic used to treat acute pain. Strong analgesics are currently admininistered 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 blood-level (pharmacokinetics) and physiological effects (pharmacodynamics) of a single dose of 0.1mg/kg diamorphine hydrochloride when administered as the nasal spray solution. Children aged 1-<16years admitted for elective surgery or laser treatment and requiring intravenous cannulation and strong analgesia will be recruited at two study sites. 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 after the child has been anaesthetised for their treatment. Blood samples will be taken before and after administration of the investigational drug. A maximum of 6 blood samples will be taken per patient. Children will receive further pain relief as required according to the normal hospital procedure. Children and research staff will complete a pain score, a scale to measure the extent of pain perceived by the patient. Potential nasal irritation will be assessed during the study. All adverse events will be recorded throughout the duration of the child??s participation in the study and for 7 days post dosing. Blood samples will be analysed at a specialist analytical laboratory. Population pharmacokinetic analysis will be performed (a non linear, mixed effects modelling approach) by a specialist pharmacokinetics group. Patients will be allowed to withdraw from the trial at any time

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  10/H0106/3

• Date of REC Opinion

  25 Feb 2010

• REC opinion

  Further Information Favourable Opinion