Emergency Department Anaphylaxis Trial II B - preliminary trial to confim pharmacokinetic profiles and study feasibility in patients with anaphylaxis treated with either intramuscular vs. intavenous adrenaline

Randomisation of patients with anaphylaxis to either intramuscular vs. intravenous adrenaline - preliminary trial to confirm pharmacokinetic profiles and study feasibility of a composite endpoint

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000282987

Acronym

EDAIIb

Enrollment

Registered

2011-03-17

Start date

2011-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Anaphylaxis is a severe potentially life-threatening allergic reaction. The accepted management is intramuscular adrenaline. With intravenous adrenaline being a last resort therapy. The investigators believe that intravenous adrenaline given slowly as a dilute infusion is a better therapy, with more rapid onset (especially in patients with low blood pressure) with a similar side-effect profile to intramuscular adrenaline. This study is part of a wider PhD assessing this hypothesis and also the pharmacological behaviour of adrenaline.

Interventions

Comparision of standard intramuscular adrenaline (0.01 mg/kg to a maximum of 0.5 mg - repeated once at 5-10 minutes as required) vs. intravenous infusion (1:100,000) titrated to effect (starting at 0.5 mls/kg/hr or 1.0 mls/kg/hr if hypotensive) in the initial management of patients with ananphylaxis

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

Any acute onset (minutes-hours) illness with typical skin features (generalised hives, pruritus or flushing, swollen lips &/or tongue), PLUS involvement of at least one other organ system (respiratory, cardiovascular, gastrointestinal) -OR- Any acute onset (minutes-hours) of hypotension or bronchospasm where anaphylaxis is considered possible, even if the typical skin features listed above are not present.

Exclusion criteria

14 years of age or less

Outcome results