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

Gordon 2007.

Methods A prospective, randomised, non‐blinded controlled clinical trial
Comparison of a single dose of IM dexamethasone versus oral prednisolone
Randomization was reported but method was not described.
Allocation concealment method was accomplished using sequentially numbered opaque study packets containing group assignments.
Participants Patients with known history of asthma who presented to the ED with moderate asthma exacerbation who did not require admission on presentation.
Asthma was defined as at least 2 prior episodes of respiratory illness treated with bronchodilators.
Clinical asthma score adapted from a previous pulmonary score was used to evaluate asthma children aged from 5 to 17 years measuring: respiratory rate, retractions and wheezing.
Reported enrolling patients with moderate exacerbations. Unable to assess exacerbation severity based on baseline PEF
Ages: enrolled patients 18 months to 7 years. Median age of IM corticosteroid group: 38 months (IQR: 29‐59). Median age of oral corticosteroid group: 42 months (IQR: 28‐60.5)
Patients who received IV therapy (not due to vomiting but to severity of asthma) were excluded from study.
Set in United States
Sex: 110 men, 71 women
Interventions
  • Interventions: single IM dose of dexamethasone (0.6 mg/kg to a maximum of 16 mg) versus oral prednisolone (2 mg/kg to a maximum of 50 mg once daily for 5 days). No placebo treatment was provided. A single dose of IV methylprednisolone (2 mg/kg) was given for patients who had repeated vomiting within 30 min after receiving oral prednisolone.

  • Co‐interventions in the ED: supplemental oxygen, albuterol, and ipratropium nebulization treatments

  • Co‐interventions at discharge: not standardized. The decision to provide patients with Inhaled beta₂‐agonists or ICS was left to the discretion of the attending physician. The use of additional systemic corticosteroids post‐discharge was allowed if prescribed by another physician.

Outcomes
  • Primary outcome: change in asthma score from the initial score on presentation to ED to the score assigned at day 4 of follow‐up visit

  • Secondary outcomes: hospital admission, respiratory signs, and need for unplanned medical visits during the 2 weeks after enrolment

Notes Authors were not contacted
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. 521): "After written informed consent was obtained, we randomised patients to 1 of 2 treatment groups in blocks of 6, 8, or 10."
Allocation concealment (selection bias) Low risk Allocation concealment ensured via sequentially numbered opaque packets containing group assignments kept in ED and opened by physician immediately after enrolment.
Quote (p. 522): "Allocation concealment was maintained by use of sequentially numbered opaque study packets containing group assignments, which were kept in the ED and opened by the treating physician immediately after enrolment."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Non‐blinded study.
Quote (p. 522): "Treating physicians were not masked to study group." "At the time of disposition from the ED or 3 hours after enrolment for those patients still in the ED, physicians not blinded to group assignment performed a standardized repeat physical examination including the assessment of a second asthma score." Quote (p. 527): "The only people masked to group assignment in this study were the investigators who assigned follow‐up scores at the 4‐day return visit."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessment completed via physician blinded to group assignment and not involved in patient's care on the initial visit.
Quote (p. 523): "At the 4‐day follow‐up visit, a physician masked to group assignment and not involved in the patient's care on the initial visit performed a standard examination, including assignment of an asthma score. Physicians and guardians were instructed not to engage in any conversation before completion of the physical examination. After completing and recording this physical examination, the physician administered a structured interview regarding interim use of bronchodilators and ICS, guardian's perception of bronchodilators and ICS, guardian's perception of clinical improvement, need for further medical care since enrolment, and compliance with oral steroid regimen."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Detailed information on study attrition provided in flow diagram provided (p. 523). Excluded patients balanced between groups.
Quote (p. 523, 525‐6): "Of 194 randomised patients, 13 were subsequently excluded from the study (7 in the dexamethasone arm and 6 in the prednisolone arm) for the following reasons: 6 had initial asthma scores of only 2, 4 had previously participated, 1 had only one prior episode of wheezing, 1 had taken prednisolone within the previous month, and 1 patient was randomised to the dexamethasone group, but inappropriately given prednisolone in the ED. The guardians of 2 included patients randomised to dexamethasone withdrew their consent for further participation during the ED visit (one before drug administration, one afterward)."
Selective reporting (reporting bias) Unclear risk No available protocol
Other bias Unclear risk Source of funding was not stated.