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Table 1 Studies identified comparing prednisolone with dexamethasone for treatment of acute exacerbations of asthma in children

From: 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

Author, date, country

Patient group

Study type

Interventions and control groups

Outcomes

Follow-up

Results

Scarfone et al., 1995, USA[18]

111 children aged one month to seven years with mild-moderate exacerbations of asthma defined by Pulmonary Index score

Single-center, prospective, randomized, double-blind double placebo trial

Oral prednisolone 2 mg/kg (max. 60 mg) for 5 days vs. nebulized dexmethasone 1.5 mg/kg (max. 45 mg) stat

Hospitalization and relapse rates and the rate and degree of clinical improvement, measured by the PI score

Follow-up phone call at 48 hours

111 children completed the study (56 Dex, 55 Pred). 21% of the dexamethasone group required hospitalization, compared to 31% of the prednisolone group. None of the dexamethasone group who were discharged, returned for further treatment compared to 6 of 38 (16%) prednisolone-treated patients.

Klig et al., 1997, USA[12]

44 children aged 3 to 16 years with more than two previous episodes of wheezing and mild to moderate wheezing episodes defined by pulmonary indexscore 2 to 7 and SaO2 ≥95%

Single-center, prospective, randomized pilot study

ED treatment with oral prednisolone 2 mg/kg (max. 100 mg) followed by 1mg/kg x two days vs. single dose of IM dexamethasone 0.3 mg/kg (max. 15 mg)

Primary outcome symptomatic improvement and relapse or deterioration defined by patients and parents; secondaryoutcomes PIS on ED discharge and further corticosteroid use after follow-up

Follow-up in clinic or by telephone on Day 5 after discharge from ED by physician blinded to patient allocation

42 children participated in the study. No significant differences between Dex and Pred groups were found for gender or age. Clinical progress (based on PI) with treatment in ED was the same in both groups: pre-treatment median, PI = 6; ED discharge median, PI = 2. None of study patients hospitalzsed during the follow-up period, and all reported symptomatic improvement since initial treatment.

Gries et al., 2000, USA[13]

33 children aged six months to seven years with mild to moderate exacerbations of asthma defined by clinicalasthma score

Single-center, prospective, randomized investigator-blinded trial

Oral prednisolone 1 mg/kg (max. 20 mg) bd x 5 days or single dose of IM dexamethasone acetate 1.7 mg/kg (max. 36 mg)

Primary outcome change in clinical asthma score, improvement in clinical status, use of bronchodilator and tolerance of steroid; secondary outcomes subjective clinical asthma score, personality changeand tolerance of medication

Clinic visits and telephone contacts on Days 3 and 7 to review parents’ diary entries. Clinic visits on Days 5 and 14, history of symptoms, diary entries and examination. Telephone contact atDay 28 to assess relapse and satisfaction. Day 14 urine cortisol-to- creatinine ratio

15 patients in the Dex group and 17 in the Pred group completed the study. Clinical asthma score improved significantly in both groups during the first five days of therapy, and no significant difference was seen in the rate of improvement between the two groups. Three patients refused more than 75% of pred doses, and another four missed 30% to 50% of doses despite parents’ best efforts. IM caused no complications, and approx. 70% of parents in both groups stated that they would choose IM Dex to treat the next asthma exacerbation.

Qureshi et al., 2001, USA[14]

628 patients aged 2 to 18 years with a history of asthma presenting with exacerbation, defined as worsening symptoms or increased difficulty breathing with worsening PEFR

Single-center, prospective randomized trial

ED treatment with single dose of oral prednisolone 2 mg/kg (max. 60 mg) followed by 1 mg/kg od for four days vs. ora l dexamethasone 0.6 mg/kg(max 16 mg) od x 2 days

Primary outcome wasrelapse rate; secondary outcomes: hospitalization, vomiting, medication compliance, persistence of symptoms, school or work days missed

A research assistant contacted each patient’s family at 11 to 14 days after ED discharge to obtain follow-up data

When Dex compared with Pred, relapse rates (7.4% of 272 vs. 6.9% of 261), hospitalization rates from ED (11% vs. 12%) or after relapse (20% vs. 17%), and symptom persistence at 10 days (22% vs. 21%) were similar. In the Pred group more children were excluded for vomiting in ED (3% vs. 0.3%; P = .008), more parents were noncompliant (4% vs. 0.4%; P = .004), and more children missed ≥2 days of school (19.5% vs. 13.2%; P = .05).

Altamimi et al., 2006, USA[15]

117 patients aged 2 to 16 years with mild to moderate exacerbation of asthma, defined as pulmonary index score <9 or PEFR >60%

Single-center prospective randomized double-blind trial

ED treatment with single dose of oral prednisolone 1 mg/kg (max. 30 mg) followed by 1 mg/kg bd for 5 days vs. oral dexamethasone 0.6 mg/kg (max. 18 mg) x single dose only

Primary outcome was the number of days for PSAS to return to baseline or PEFR to return to >80% predicted; secondary outcomes were short-term improvement in PEFR and PIS at discharge from ED, time to discharge, number of salbutamol therapies in ED and at home, unexpected returns to ED, need for admission after discharge and improvement in PIS on Day 5

Telephone call at 48 hrs to assess progress using standard assessment form. Re-assessment at Day 5 of salbutamol treatments, side effects, unscheduled visits to a doctor, review of PSAS sheet, examination and compliance. Ifsymptoms were ongoing at Day 5, patient had weeklyphone call for three weeks

Baseline characteristics similar. Mean no. days needed for PSAS return to baseline (0 to 0.5) in the Dex and Pred groups were 5.21vs 5.22 days, respectively (mean difference, -0.01; CI, -0.70, 0.68). PI scores similar in both groups at initial presentation, initial ED discharge and at Day 5 follow-up visit. At first visit, mean time to discharge was 3.5 h (± 1.93) for Dex and 4.3 h (± 3.67) for Pred (mean difference, -0.8; CI, -1.8, 0.2). Initial admission rate 9% (Dex) versus 13.4% (Pred). No significant difference in no. salbutamol therapies needed in ED or at home after discharge. For subjects discharged home, admission rate after initial discharge was 4.9% (Dex) vs. 1.8% (Pred), resulting in overall hospital admission rates of 13.4% (Dex) and 14.9% (Pred).

Gordon et al., 2007, USA[16]

194 children aged 18 months to 7 years with moderate exacerbations of asthma defined as clinical asthma score 3 to 7

Single-center, prospective, randomized trial

Oral prednisolone 2 mg/kg (max. 50 mg) daily x 5 days vs. single dose of IM dexamethasone 0.6 mg/kg (max. 15 mg) IM

Primary outcome waschange in asthma scorefrom presentation to score at four-day follow-up. Secondary outcomes were hospital admission on first presentation, by four days and by two weeks, respiratory symptoms at four days and need for unplanned medical visits during two weeks post enrollment

Scheduled follow-up at 96 to 120 hrs post-enrollment andtelephone interview at two weeks to assess secondary outcomes

89 patients randomized to dex and 93 to pred. Group characteristics similar at baseline. Among those discharged from the ED, 62 (90%) of 69 and 64 (90%) of 74 patients in the dex and pred groups, respectively, were reassessed at four days for primary outcome. Mean change in total asthma score 3.6 in dex group and 3.4 in pred group (difference, 0.2; 95% CI, -0.4 to 0.7). Of pts initially discharged, 5.9% of dex pts and 4.1% of pred pts were admitted before two-week follow-up (difference, 1.8%; 95% CI, -5.4% to 9.0%).

Greenberg et al., 2008, USA[17]

89 children aged 2 to 18 years with any exacerbation of asthma

Prospective, randomized, double-blind conveniencestudy at urban, tertiary care, academic children’s hospital ED

0.6 mg/kg of oral dexamethasone (max dose 16 mg) or 2 mg/kg of oral prednisone (max. 80 mg) during ED treatment. At ED discharge, pts in dex arm received one dose of 0.6 mg/kg dex to take next day and placebo to take BD tocomplete five-day course.Pts in pred arm received 1 mg/kg pred to take twice daily for five days.

Primary outcome wasrelapse within 10 days, defined as need for subsequent hospitalizationor unscheduled visit with a medical provider. Secondary outcome was emesis with steroid administration in the ED.

Patients and their families were called by telephone 10 days after their ED visit for follow-up.

89 patients completed study: 38 in pred group and 51 in dex group. 3 patients in pred group (8%) and 8 patients in dex group (16%) required an unscheduled follow-up visit (P = .27). 7 patients in pred group (18%) and 5 patients in dex group (10%) had vomiting (P = .24). No difference found in relapse rate or incidence of vomiting between patients given pred and dex for asthma exacerbations.