The IMP is to be used as an analgesic for the relief of acute pain. MedDRA version: 12.0 Level: LLT Classification code 10002182 Term: Analgesia
Conditions
Sponsors
Wockhardt UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged from 2 – =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the safety of intranasal diamorphine in children from the time they receive Diamorphine Hydrochloride Nasal Spray until their discharge from the emergency department (normally up to 4 hours).;Secondary Objective: To obtain information on the potential nasal irritation when diamorphine is delivered intranasally to children;Primary end point(s): Primary Endpoint: Safety Profile as measured by: • Adverse event category according to the current version of MedDRA. Secondary endpoints: • Nasal irritation by classification and severity • Glasgow Coma Scores • Pupil dilation • Respiratory rate • Pulse rate • Oxygen saturation | — |
Countries
United Kingdom
Outcome results
None listed