An open label single dose pharmacokinetic study of Diamorphine Hydrochloride Nasal Spray (0.06mg/kg) in children - DIAPOP STUDY

Wockhardt UK Limited0 个研究点开始时间: 2010年3月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Male or female aged from 1 – <16 years of age.
•2. Scheduled to attend the hospital for minor day surgery or laser treatment.
•3. Requiring opiate analgesia for pain relief.
•4. Weight in range of 10 - 70 kg.
•5. Parent(s) or legal guardian in attendance.
•6. Parent(s)/legal guardian able and willing to provide written informed consent for the child to take part in the study.
•7. Where applicable, the child should assent to undergo blood sampling for pharmacokinetic purposes and to allow physiological measurements to be made.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Presence of airway/respiratory problems.
•2. Evidence or history of epistaxis.
•3. Known allergy to opiate medication or any excipients of the nasal spray (benzalkonium chloride and disodium edetate [ethylenediaminetetraacetic acid (EDTA)]).
•4. Exposure to opiate analgesia in the preceding 7 days.
•5. Exposure to drugs known to pharmacokinetically interact with diamorphine in the preceding 7 days.
•6. Receiving any chronic medication, except inhaled asthma therapies. Patients that have received periodic simple analgesics such as paracetamol, ibuprofen etc will not be excluded.
•7. Head injury or neurological problem.
•8. Treatment with monoamine oxidase inhibitors in the previous 14 days.
•9. Participation in a clinical study in the previous 30 days.
•10. Patient trauma requiring cardiovascular resuscitation.
•11. Females who are pregnant, lactating or planning to become pregnant.

发起方