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Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00124995
Enrollment
40
Registered
2005-07-29
Start date
2003-10-31
Completion date
2006-10-31
Last updated
2013-02-15

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

Conditions

Status Asthmaticus

Brief summary

Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.

Interventions

Sponsors

Connecticut Children's Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years

Inclusion criteria

* Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus * Modified Pulmonary Index Score (MPIS) of greater than or equal to 12 * Age between birth and 18 years old

Exclusion criteria

* Pre-existing cardiac or pulmonary disease * Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation) * Hemodynamic or cardiovascular instability requiring inotropic support * The patient meets one of the criteria for withdrawal from the study due to patient safety concerns

Design outcomes

Primary

MeasureTime frame
ICU length of stay

Secondary

MeasureTime frame
To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
To prospectively analyze the side effects of terbutaline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026