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Evaluation of Three Doses of Nebulized Epinephrine in Post-Extubation Croup

In infants and children experiencing post-extubation stridor, is a 0.5, 2.5 or 5ml dose of Nebulized L-Epinephrine more effective in reducing stridor (Westley score)? A Prospective Randomized Double-Blind Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000759099
Enrollment
72
Registered
2010-09-14
Start date
2010-10-01
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

Although the use of nebulized epinephrine has been well studied and has a long history of use in children with viral croup, there is a few prospective studies investigating the effect of epinephrine on postextubation croup. However, there is no consensus in the literature regarding the appropriate dose of nebulized 1:1000 l-adrenaline that should be used to preventing postextubation croup. The aim of this study is to compare the effectiveness and safety of nebulized l-epinephrine at dosage of 0.5 mL, 2.5 mL and 5 mL in the treatment of postextubation stridor

Interventions

Intervention:nebulized l-epinephrine (1:1000) Doses: 0.5 mL or 2.5 mL or 5 mL Mode of administration: nebulization by face mask Duration: 15 minutes Patients will be assigened to one of three study treatments at 15 minutes post-extubation: 5 mL of l-adrenaline 1:1000 (group 1), 2.5 mL of l-adrenaline 1:1000 (group 2) or 0.5 mL of l-adrenaline 1:1000 (group 3). If the amount of l-epinephrine was less than 5 mL, isotonic saline was added until the volume achieved 5 mL. Research nurse will admini

Intervention:nebulized l-epinephrine (1:1000) Doses: 0.5 mL or 2.5 mL or 5 mL Mode of administration: nebulization by face mask Duration: 15 minutes Patients will be assigened to one of three study treatments at 15 minutes post-extubation: 5 mL of l-adrenaline 1:1000 (group 1), 2.5 mL of l-adrenaline 1:1000 (group 2) or 0.5 mL of l-adrenaline 1:1000 (group 3). If the amount of l-epinephrine was less than 5 mL, isotonic saline was added until the volume achieved 5 mL. Research nurse will administer nebulizations over 15 minutes with a small, tight-fitting plastic face mask with an updraft nebulizer (Hudson RCI, Teleflex Medical, USA) connected to a source of pressurized oxygen with continuous flow of 100% oxygen at 5 L/min. The nebulizers will be administered until empty.

Sponsors

Paulo Sergio Lucas da Silva
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
1 Months to 16 Years
Healthy volunteers
No

Inclusion criteria

Patients presenting hoarseness, a barking cough and inspiratory stridor after extubation and a Westley score more than 3.

Exclusion criteria

Previous history of subglottic stenosis, laryngomalacia, infectious croup or use of corticosteroids within 48 hours prior to extubation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026