Use of Dexamethasone in Pediatric Asthma Exacerbations

NCT ID: NCT02192827

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-03-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Dose Dexamethasone

0.6 mg/kg of Dexamethasone Sodium Phosphate Injection 10mg/1ml given with equivalent volume of cherry syrup given orally once

Group Type: EXPERIMENTAL

Dexamethasone Sodium Phosphate Injection

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Dexamethasone Sodium Phosphate Injection

Intervention Type: DRUG

Interventions

Dexamethasone Sodium Phosphate Injection

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Meghan Martin

Pediatric Emergency Medicine Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meghan E Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Locations

Women and Children's Hospital Of Buffalo

Buffalo, New York, United States

Countries

United States

References

Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28.

Reference Type: BACKGROUND

PMID: 26712860 (View on PubMed)

National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

Reference Type: BACKGROUND

PMID: 17983880 (View on PubMed)

Chapman KR, Verbeek PR, White JG, Rebuck AS. Effect of a short course of prednisone in the prevention of early relapse after the emergency room treatment of acute asthma. N Engl J Med. 1991 Mar 21;324(12):788-94. doi: 10.1056/NEJM199103213241202.

Reference Type: BACKGROUND

PMID: 1997850 (View on PubMed)

Rachelefsky G. Treating exacerbations of asthma in children: the role of systemic corticosteroids. Pediatrics. 2003 Aug;112(2):382-97. doi: 10.1542/peds.112.2.382.

Reference Type: BACKGROUND

PMID: 12897291 (View on PubMed)

Scarfone RJ, Fuchs SM, Nager AL, Shane SA. Controlled trial of oral prednisone in the emergency department treatment of children with acute asthma. Pediatrics. 1993 Oct;92(4):513-8.

Reference Type: BACKGROUND

PMID: 8414819 (View on PubMed)

Zoorob RJ, Cender D. A different look at corticosteroids. Am Fam Physician. 1998 Aug;58(2):443-50.

Reference Type: BACKGROUND

PMID: 9713398 (View on PubMed)

Cronin J, Kennedy U, McCoy S, An Fhaili SN, Crispino-O'Connell G, Hayden J, Wakai A, Walsh S, O'Sullivan R. Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial. Trials. 2012 Aug 21;13:141. doi: 10.1186/1745-6215-13-141.

Reference Type: BACKGROUND

PMID: 22909281 (View on PubMed)

Karaman M, Ilhan AE, Dereci G, Tek A. Determination of optimum dosage of intraoperative single dose dexamethasone in pediatric tonsillectomy and adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2009 Nov;73(11):1513-5. doi: 10.1016/j.ijporl.2009.06.001. Epub 2009 Jul 10.

Reference Type: BACKGROUND

PMID: 19801100 (View on PubMed)

Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.

Reference Type: BACKGROUND

PMID: 11445789 (View on PubMed)

Greenberg RA, Kerby G, Roosevelt GE. A comparison of oral dexamethasone with oral prednisone in pediatric asthma exacerbations treated in the emergency department. Clin Pediatr (Phila). 2008 Oct;47(8):817-23. doi: 10.1177/0009922808316988. Epub 2008 May 8.

Reference Type: BACKGROUND

PMID: 18467673 (View on PubMed)

Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.

Reference Type: BACKGROUND

PMID: 24515516 (View on PubMed)

Kelly CS, Andersen CL, Pestian JP, Wenger AD, Finch AB, Strope GL, Luckstead EF. Improved outcomes for hospitalized asthmatic children using a clinical pathway. Ann Allergy Asthma Immunol. 2000 May;84(5):509-16. doi: 10.1016/S1081-1206(10)62514-8.

Reference Type: BACKGROUND

PMID: 10831004 (View on PubMed)

Chang AB, Clark R, Sloots TP, Stone DG, Petsky HL, Thearle D, Champion AA, Wheeler C, Acworth JP. A 5- versus 3-day course of oral corticosteroids for children with asthma exacerbations who are not hospitalised: a randomised controlled trial. Med J Aust. 2008 Sep 15;189(6):306-10. doi: 10.5694/j.1326-5377.2008.tb02046.x.

Reference Type: BACKGROUND

PMID: 18803532 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

647430-4

Identifier Type: -

Identifier Source: org_study_id