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. 2018 Jun 2;2018(6):CD012629. doi: 10.1002/14651858.CD012629.pub2

Al‐Wahadneh 2006.

Methods A prospective, randomised, non‐blinded clinical trial
Comparison of IM dexamethasone to oral prednisolone
Randomisation and allocation concealment methods were reported but methods were not described
Participants Patients with known history of asthma who presented to the ED with a moderate asthma exacerbation who did not require admission on presentation and had no evidence of varicella exposure or fever and did not take any systemic corticosteroids within 2 weeks of the start of the study
A locally modified scoring system based on GINA guidelines for the management of asthma was used to evaluate the clinical response at presentation, and 5 days after treatment.
Ages: enrolled patients 9 months to 14 years. Mean age of IM corticosteroid group: 79.7 months. Mean age of oral corticosteroid group: 45.4 months
Reported enrolling patients with mild‐moderate exacerbations. Unable to assess exacerbation severity based on baseline PEF
Set in Jordan
Sex: 20 men, 9 women
Interventions
  • Interventions: single IM dose of dexamethasone (1.7 mg/kg; mean steroid dosage: 24 mg) versus oral prednisolone (2 mg/kg/day; mean steroid dosage: 19.2 mg per day) for 5 days. No placebo was provided for either group

  • Co‐interventions in the ED: not reported

  • Co‐interventions at discharge: salbutamol (100 mcg/puff; 1 puff every 4 to 6 hours as needed)

Outcomes
  • Change in clinical asthma score from day 1 through day 5 of treatment.

  • Relapse (defined as unscheduled patient returns due to symptoms and signs requiring treatment with systemic corticosteroids after initial clearance within 21 days of treatment)

  • Clearing of an asthma exacerbation (defined as resolving of asthma symptoms and signs, the use of salbutamol less than 2 puffs per day and an additional course of systemic corticosteroids were not considered necessary)

Notes Authors did not respond to requests for clarification.
No registered protocol was identified.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided on how patients were randomised.
Quote (p. 16): "Patients were randomised to receive either a single Intramuscular (IM) dose of dexamethasone acetate (1.7 mg/kg) or prednisolone taken orally each day for 5 days (2 mg/kg//day)."
Allocation concealment (selection bias) Unclear risk Study did not comment on allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Reported as a non‐blinded study.
Quote (p. 16): "The study is prospective randomised and non‐blinded."
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Reported as a non‐blinded study.
Quote (p. 16): "The study is prospective randomised and non‐blinded."
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient reporting of attrition/exclusions to permit a judgement.
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Unclear risk Source of funding not provided. Baseline imbalance detected, dexamethasone group significantly older than prednisolone group.
Quote (p. 16): "Males out‐numbered females in both groups (13:4 in the dexamethasone group, and 7:5 in the second group). Patients in dexamethasone acetate group were older than those in prednisolone group (P = 0.007), which can risk of bias ably be explained by the small‐sized sample and the random assignment of patients to either group."