Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 399 for:    sodium phosphate

Use of Dexamethasone in Pediatric Asthma Exacerbations

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.
ClinicalTrials.gov Identifier: NCT02192827
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Meghan Martin, Johns Hopkins All Children's Hospital

Brief Summary:
The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs. two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.

Condition or disease Intervention/treatment Phase
Asthma Drug: Dexamethasone Sodium Phosphate Injection Phase 3

Detailed Description:

The emergency department (ED) physician will follow the standard asthma care path to manage a pediatric asthma patient whether the patient meets study criteria or not. Patients' legal guardian will be approached for consent if patient meets the study criteria. Once the consent is obtained, the patient will be randomized into one of the two study groups according to a randomization table generated by a statistician. The first group will receive a single dose of dexamethasone sodium phosphate injection (0.6 mg/kg with max of 16 mg) mixed with equivalent volume of cherry syrup given orally in the ED. The second group will receive a first dose of dexamethasone with cherry syrup (also 0.6 mg/kg with max of 16 mg) in the ED, and a second dose will be prescribed to the patient at home on the day following the ED visit. This dose will be the same dosage of dexamethasone, but may be a pill or liquid form. Patients will continue their previously prescribed asthma regimen and albuterol as needed. Children who vomit the steroids in the ED will be re-dosed. Children who vomit the steroid a second time will be excluded from the study.

2. Data collection. Demographic information such as age, race, duration of asthma symptoms, number of previous hospitalizations, and current medication will be collected on an ED data collection form. Pertinent exam findings such as patient's vital signs, pulse oximetry, peak flow, Pediatric asthma severity score (PAS), patient asthma severity self-assessment sheets (PSAS), and ED treatment will also be collected on an ED data collection form.

After discharge from the ED, patients will be instructed to complete the PSAS and measure peak flows on a daily basis for 5 days. These data will be documented on a home patient self-assessment sheet by the legal guardian. The investigators will train the legal guardians on how to complete the PSAS and measure peak flows in the ED. The peak flow meters are offered to the patients as part of the asthma care path.

3. Phone follow-up All patients will be contacted by phone by a research assistant 5 days after the ED visit. Information collected during the phone interview will include PSAS, peak flows, unexpected visits to medical providers (ED, primary care or urgent care) for asthma symptoms, school days missed due to asthma exacerbation, length of time symptoms persisted, compliance with the recommended steroid regimen, vomiting, other side effects or medication administration problems caused by the steroids.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose Dexamethasone is as Effective as Two Doses in Mild to Moderate Pediatric Asthma Exacerbations in the Emergency Department
Study Start Date : April 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: Single Dose Dexamethasone
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Drug: Dexamethasone Sodium Phosphate Injection
Experimental: Two Dose Dexamethasone
0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once in the Emergency room, followed by another dose of dexamethasone at home, which will be prescribed from the ED. The second dose will be the same dosage, but will be prescribed and may be pill or liquid form.
Drug: Dexamethasone Sodium Phosphate Injection



Primary Outcome Measures :
  1. Peak Flow [ Time Frame: 5 days ]
    Peak flow will be measured while patient is in the Emergency Department, and will be measured at home by patient for 5 days following discharge to determine the degree of improvement toward predicted normal value.


Secondary Outcome Measures :
  1. Return to care [ Time Frame: 5 days ]
    The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.


Other Outcome Measures:
  1. Side effects [ Time Frame: 5 days ]
    The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 2 to 20 years, from all race and ethnicity groups, with a known history of asthma who present to the Emergency Department of Women and Children's Hospital of Buffalo with an acute exacerbation of mild or moderate asthma are potentially eligible for the study. Patients with severe asthma exacerbations will require intravenous steroid therapy, therefore, they will not be enrolled in the study. The investigators plan to enroll patients from winter of 2014 to fall 2016.

History of asthma is defined by physician diagnosis of at least 1 prior episode of wheezing which responded to beta agonist medication.

Mild asthma is defined as: Pediatric Asthma Score (PAS) of 5 to 7; Moderate asthma is defined as: PAS of 8 to 11; Severe asthma is defined as: PAS of 12 or more.

Exclusion Criteria:

  • Children who have one of the following conditions will be excluded from the study: are less than 2 years of age, have signs of severe exacerbation (Pediatric Asthma Score of more than 11), have used oral steroids in the last 2 weeks, have chronic lung disease (e.g., cystic fibrosis), have been given IV solumedrol, or vomit two doses of dexamethasone in emergency department.

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 ClinicalTrials.gov identifier (NCT number): NCT02192827


Locations
Layout table for location information
United States, New York
Women and Children's Hospital Of Buffalo
Buffalo, New York, United States, 14222
Sponsors and Collaborators
University at Buffalo
Investigators
Layout table for investigator information
Principal Investigator: Meghan E Martin, MD University at Buffalo, The State University of New York

Layout table for additonal information
Responsible Party: Meghan Martin, Pediatric Emergency Medicine Attending Physician, Johns Hopkins All Children's Hospital
ClinicalTrials.gov Identifier: NCT02192827     History of Changes
Other Study ID Numbers: 647430-4
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

Keywords provided by Meghan Martin, Johns Hopkins All Children's Hospital:
Pediatric
Asthma
Exacerbation
Dexamethasone
Peak flow

Additional relevant MeSH terms:
Layout table for MeSH terms
Dexamethasone 21-phosphate
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action