An open label, single dose safety study of Diamorphine Hydrochloride Nasal Spray (0.1mg/kg) in children - DIASAFE 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 2 – <16 years of age.
•2. Suffering from suspected clinical fractures or trauma which requires immediate pain relief as part of their routine treatment.
•3. To be administered diamorphine hydrochloride for pain relief by the attending physician.
•4. Weight in range of 12 - 50 kg.
•5. Parent(s) or legal guardian in attendance.
•6. Parent(s)/legal guardian must be able and willing to provide written informed consent.
•7. Where applicable, subject should assent to allow their safety and nasal irritation data to be used for the study.
•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 drugs known to pharmacokinetically interact with diamorphine in the preceding 7 days.
•5. Exposure to opiate analgesia in the preceding 7 days.
•6. Head injury or neurological problem.
•7. Treatment with monoamine oxidase inhibitors in the previous 14 days.
•8. Participation in a clinical study in the previous 30 days.
•9. Subject trauma requiring cardiovascular resuscitation.
•10. Females who are pregnant, lactating or planning to become pregnant.

发起方