Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study)

Respati W Ranakusuma; Amanda R McCullough; Eka D Safitri; Yupitri Pitoyo; Widyaningsih Widyaningsih; Christopher B Del Mar; Elaine M Beller

doi:10.1186/s40814-020-00671-5

Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study)

Pilot Feasibility Stud. 2020 Aug 29:6:121. doi: 10.1186/s40814-020-00671-5. eCollection 2020.

Authors

Respati W Ranakusuma^{1

2}, Amanda R McCullough¹, Eka D Safitri², Yupitri Pitoyo², Widyaningsih Widyaningsih², Christopher B Del Mar¹, Elaine M Beller¹

Affiliations

¹ Institute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD 4226 Australia.
² Clinical Epidemiology and Evidence-Based Medicine Unit, Dr. Cipto Mangunkusumo General Hospital - Faculty of Medicine Universitas Indonesia, Diponegoro 71, Jakarta, 10430 Indonesia.

Abstract

Background: Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); however, they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. Evidence for the efficacy of these remains inconclusive. We conducted a pilot study to test feasibility of a proposed large-scale randomised controlled trial (RCT) to assess the efficacy of corticosteroids for AOM.

Methods: We conducted a pilot, pragmatic, parallel, open-label RCT of oral corticosteroids for paediatric AOM in primary and secondary/tertiary care centres in Indonesia. Children aged 6 months-12 years with AOM were randomised to either prednisolone or control (1:1). Physicians were blinded to allocation. Our objectives were to test the feasibility of our full RCT procedures and design, and assess the mechanistic effect of corticosteroids, using tympanometry, in suppressing middle ear inflammation by reducing MEE.

Results: We screened 512 children; 62 (38%) of 161 eligible children were randomised and 60 were analysed for the primary clinical outcome. All study procedures were completed successfully by healthcare personnel and parents/caregivers, despite time constraints and high workload. All eligible, consenting children were appropriately randomised. One child did not take the medication and four received additional oral corticosteroids. Our revised sample size calculation verified 444 children are needed for the full RCT. Oral corticosteroids did not have any discernible effects on MEE resolution and duration. There was no correlation between pain or other symptoms and MEE change. However, prednisolone may reduce pain intensity at day 3 (Visual Analogue Scale mean difference - 7.4 mm, 95% confidence interval (CI) - 13.4 to - 1.3, p = 0.018), but cause drowsiness (relative risk (RR) 1.8, 95% CI 1.1 to 2.8, p = 0.016). Tympanometry curves at day 7 may be improved (RR 1.8, 95% CI 1.0 to 2.9). We cannot yet confirm these as effects of corticosteroids due to insufficient sample size in this pilot study.

Conclusions: It is feasible to conduct a large, pragmatic RCT of corticosteroids for paediatric AOM in Indonesia. Although oral corticosteroids may reduce pain and improve tympanometry curves, it requires an adequately powered clinical trial to confirm this.

Trial registration: Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.

Keywords: Acoustic impedance tests; Acute disease; Anti-bacterial agents; Corticosteroids; Glucocorticoids; Middle ear effusion; Otitis media; Pilot projects.