Asthma
Conditions
Keywords
Pediatric, Asthma, Exacerbation, Dexamethasone
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.
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, 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 on a daily basis for 5 days. The 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 in the ED. 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, 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.
Interventions
Sponsors
University at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Returning to Care Following Discharge From the Emergency Department | 5 days | The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reported Number of Days Until Symptom Resolution | 5 days | Will determine number of days to symptom resolution, including missed school days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reported Side Effects Experienced by Participants | 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. |
Countries
United States
Participant flow
Recruitment details
Patients presenting with asthma symptoms to a single pediatric emergency department
Pre-assignment details
Excluded 10 Patients: Previously enrolled into the study: 2 Admitted to the PICU (pediatric intensive care unit): 5 Required IV steroids in the Emergency Dept: 1 Steroid use within the last 2 weeks: 1 Excessive vomiting in the Emergency Dept: 1
Participants by arm
| Arm | Count |
|---|---|
| Single Dose Dexamethasone 0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once
Dexamethasone Sodium Phosphate Injection | 116 |
| 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 Department (ED), 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.
Dexamethasone Sodium Phosphate Injection | 116 |
| Total | 232 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Given additional steroids with admission | 13 | 11 |
| Overall Study | Lost to Follow-up | 25 | 27 |
Baseline characteristics
| Characteristic | Total | Single Dose Dexamethasone | Two Dose Dexamethasone |
|---|---|---|---|
| Age, Continuous | 7.5 years STANDARD_DEVIATION 4.2 | 6.8 years STANDARD_DEVIATION 3.9 | 8.2 years STANDARD_DEVIATION 4.4 |
| Current use of asthma controller medication | 104 Participants | 50 Participants | 54 Participants |
| Number of days with symptoms | 3.3 days STANDARD_DEVIATION 8.7 | 3.6 days STANDARD_DEVIATION 9.7 | 3.1 days STANDARD_DEVIATION 7.5 |
| Number of previous hospital admissions | 1.3 admissions STANDARD_DEVIATION 2.2 | 1.4 admissions STANDARD_DEVIATION 1.9 | 1.2 admissions STANDARD_DEVIATION 2.5 |
| Pediatric Asthma Score before albuterol administered | 7.1 PAS score STANDARD_DEVIATION 1.6 | 7.2 PAS score STANDARD_DEVIATION 1.8 | 6.9 PAS score STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 113 Participants | 61 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 45 Participants | 21 Participants | 24 Participants |
| Race (NIH/OMB) White | 61 Participants | 28 Participants | 33 Participants |
| Sex: Female, Male Female | 92 Participants | 48 Participants | 44 Participants |
| Sex: Female, Male Male | 140 Participants | 68 Participants | 72 Participants |
| Tobacco exposure in home | 63 Participants | 32 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 116 |
| other Total, other adverse events | 20 / 116 | 10 / 116 |
| serious Total, serious adverse events | 0 / 116 | 0 / 116 |
Outcome results
Primary
Number of Participants Returning to Care Following Discharge From the Emergency Department
The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician.
Time frame: 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Dose Dexamethasone | Number of Participants Returning to Care Following Discharge From the Emergency Department | 14 Participants |
| Two Dose Dexamethasone | Number of Participants Returning to Care Following Discharge From the Emergency Department | 12 Participants |
Secondary
Reported Number of Days Until Symptom Resolution
Will determine number of days to symptom resolution, including missed school days.
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Dose Dexamethasone | Reported Number of Days Until Symptom Resolution | 2.4 Days | Standard Deviation 3.5 |
| Two Dose Dexamethasone | Reported Number of Days Until Symptom Resolution | 2.5 Days | Standard Deviation 3.4 |
Other Pre-specified
Reported Side Effects Experienced by Participants
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.
Time frame: 5 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Dose Dexamethasone | Reported Side Effects Experienced by Participants | Difficulty Sleeping | 9 Participants |
| Single Dose Dexamethasone | Reported Side Effects Experienced by Participants | Headache | 3 Participants |
| Single Dose Dexamethasone | Reported Side Effects Experienced by Participants | Decreased Appetite | 4 Participants |
| Single Dose Dexamethasone | Reported Side Effects Experienced by Participants | Other | 5 Participants |
| Single Dose Dexamethasone | Reported Side Effects Experienced by Participants | Mood swings/Agitation | 7 Participants |
| Single Dose Dexamethasone | Reported Side Effects Experienced by Participants | Multiple | 17 Participants |
| Single Dose Dexamethasone | Reported Side Effects Experienced by Participants | No side effects | 71 Participants |
| Two Dose Dexamethasone | Reported Side Effects Experienced by Participants | Multiple | 18 Participants |
| Two Dose Dexamethasone | Reported Side Effects Experienced by Participants | No side effects | 83 Participants |
| Two Dose Dexamethasone | Reported Side Effects Experienced by Participants | Decreased Appetite | 7 Participants |
| Two Dose Dexamethasone | Reported Side Effects Experienced by Participants | Difficulty Sleeping | 0 Participants |
| Two Dose Dexamethasone | Reported Side Effects Experienced by Participants | Mood swings/Agitation | 3 Participants |
| Two Dose Dexamethasone | Reported Side Effects Experienced by Participants | Headache | 1 Participants |
| Two Dose Dexamethasone | Reported Side Effects Experienced by Participants | Other | 4 Participants |