Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00124995
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center

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.

Condition or disease Intervention/treatment Phase
Status Asthmaticus Drug: terbutaline Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
Study Start Date : October 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. ICU length of stay

Secondary Outcome Measures :
  1. To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
  2. To prospectively analyze the side effects of terbutaline

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00124995

United States, Connecticut
CT Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Principal Investigator: Christopher Carroll, MD CT Children's Medical Center

Responsible Party: Christopher Carroll, MD, Associate Professor of Pediatrics, Connecticut Children's Medical Center Identifier: NCT00124995     History of Changes
Other Study ID Numbers: 05-001
First Posted: July 29, 2005    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action