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

Conditions: The IMP is to be used as an analgesic for the relief of acute pain.
MedDRA version: 12.0Level: LLTClassification code 10002182Term: Analgesia

Registration Number: EUCTR2009-014983-20-GB

Lead Sponsor: Wockhardt UK Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

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 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the single dose pharmacokinetic profile of intranasally administered diamorphine in children aged 1-<16 years.;Primary end point(s): - Pharmacokinetic parameters:<br> (Metabolites: Acetylmorphine, Morphine, Morphine-3-glucuronide, Morphine-6-glucuronide)<br><br>Pharmacodynamic parameters:<br>• Post operative pain scores<br>• Respiratory rate<br>• Pulse rate<br>• Oxygen saturation <br>• Temperature<br><br>Safety parameters:<br>- Adverse event monitoring<br>- Local tolerability (nasal irritation);Secondary Objective: • To obtain pharmacodynamic endpoints (post operative pain scores, pupil dilation, respiratory rate, pulse rate, oxygen saturation and temperature)<br><br>• To investigate the relationship between the pharmacokinetics of intranasal diamorphine and pharmacodynamic endpoints.<br><br>• To provide additional safety information (particularly nasal irritation effects) to the current profile for intranasal diamorphine in a hospital clinic day surgery setting in children.<br>

Secondary Outcome Measures