Use of Dexamethasone in Pediatric Asthma Exacerbations
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|ClinicalTrials.gov Identifier: NCT02192827|
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Dexamethasone Sodium Phosphate Injection||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||318 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
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
|United States, New York|
|Women and Children's Hospital Of Buffalo|
|Buffalo, New York, United States, 14222|
|Principal Investigator:||Meghan E Martin, MD||University at Buffalo, The State University of New York|