CompletedPhase 3ACTRN12610000759099

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


Sponsor

Paulo Sergio Lucas da Silva

Enrollment

72 participants

Start Date

Oct 1, 2010

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 1 MonthsMax Age: 16 Yearss

Inclusion Criteria1

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

Exclusion Criteria1

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

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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 st

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.


Locations(1)

Brazil

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