Anaphylaxis
Conditions
Keywords
Intranasal epinephrine, Plasma epinephrine level
Brief summary
This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.
Detailed description
Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.
Interventions
DRUGEpinephrine
1. Intranasal epinephrine 5 mg /spray 2. Intramuscular epinephrine 0.3 mg 3. Intranasal saline spray
Sponsors
Mahidol University
Siriraj Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects 2. 18-30 years-old
Exclusion criteria
1. Pregnancy 2. Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Pharmacokinetics of epinephrine | predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose | Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of participants with adverse events as a measure of safety and tolerability | 1 year | Any side effects from such administration such as bad smelling, sorethroat. |
Countries
Thailand
Outcome results
None listed