Inhaled Steroids for Acute Pharyngitis.

Summary

Background: Acute pharyngitis (AP) is a common presentation to the Emergency Department (ED). Most AP patients' who present to the ED are interested in relief their sore throat (pain). There are different approaches available in the literature to control AP pain. Studies have shown that the use of systemic glucocorticoids significantly decreases patients' sore throat. Up to our knowledge, there are no available trials looking at the role of nebulized glucocorticoids in treating infective AP. Aim: Our aim is to investigate in pediatrics and adults population ≥5 years presenting to ED with AP if the use of a single dose of nebulized glucocorticoids as an adjunct to standard AP treatment, compared with placebo leads to complete resolution or improvement in symptoms. Method: The investigators are planning to conduct a multi-center, double-blind randomized control trial. There will be three arms; first arm: nebulized Budesonide, second arm: nebulized Dexamethasone and third arm: placebo nebulized Normal Saline (NS). The patients will be followed up for 7 days through phone calls to assess the primary and secondary outcomes. Our primary objective is to investigate whether the use of a single dose of nebulized glucocorticoids compared with placebo leads to significant improvement or complete resolution of the sore throat within 24hrs. Our secondary objectives are to assess if a single dose of glucocorticoids will: reduce sore throat at 48 hours, reduce absence from work or school, reduce the incidence of hospital admission, and reduce the rate of re-attendance to ED. Since there is no available data about the effect of nebulized glucocorticoids in AP, the appropriate sample size will be calculated after running a pilot study. The data will be recorded in the EpiData@ software. Then the data will be analyzed using the SPSS@ software. The ethical approval was sought from the ethical committee in each participating hospital and they approved it. Results: The result of this study will be presented in local conferences as well in international conferences. The investigators will aim to publish the study in a well-known international emergency medicine journal. Clinical application: up to our knowledge this study is the first study worldwide looking at the effect of nebulized glucocorticoids in patients with infective acute pharyngitis. As mentioned earlier that there are multiple approaches available in the literature to control sore throat pain and if our hypothesis turned to be correct then another alternative treatment can be added. The investigators believe that the use of topical route to administer glucocorticoids is more convenient for physicians and have less chance to develop adverse effect in comparison to systemic steroids.

Timeline

Start

2019-06-01

Primary completion

2022-05-30

Completion

2022-05-30

Publications

• Results Schappert SM, Rechtsteiner EA. Ambulatory medical care utilization estimates for 2006. Natl Health Stat Report. 2008 Aug 6;(8):1-29.
• Results van Driel ML, De Sutter A, Deveugele M, Peersman W, Butler CC, De Meyere M, De Maeseneer J, Christiaens T. Are sore throat patients who hope for antibiotics actually asking for pain relief? Ann Fam Med. 2006 Nov-Dec;4(6):494-9. doi: 10.1370/afm.609.
• Results Schachtel BP, Fillingim JM, Thoden WR, Lane AC, Baybutt RI. Sore throat pain in the evaluation of mild analgesics. Clin Pharmacol Ther. 1988 Dec;44(6):704-11. doi: 10.1038/clpt.1988.215.
• Results Sadeghirad B, Siemieniuk RAC, Brignardello-Petersen R, Papola D, Lytvyn L, Vandvik PO, Merglen A, Guyatt GH, Agoritsas T. Corticosteroids for treatment of sore throat: systematic review and meta-analysis of randomised trials. BMJ. 2017 Sep 20;358:j3887. doi: 10.1136/bmj.j3887.
• Results Hayward G, Thompson MJ, Perera R, Glasziou PP, Del Mar CB, Heneghan CJ. Corticosteroids as standalone or add-on treatment for sore throat. Cochrane Database Syst Rev. 2012 Oct 17;10:CD008268. doi: 10.1002/14651858.CD008268.pub2.
• Results Hayward GN, Hay AD, Moore MV, Jawad S, Williams N, Voysey M, Cook J, Allen J, Thompson M, Little P, Perera R, Wolstenholme J, Harman K, Heneghan C. Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in Adults: A Randomized Clinical Trial. JAMA. 2017 Apr 18;317(15):1535-1543. doi: 10.1001/jama.2017.3417.
• Results Atef K Salama, Ahmed M El-badawy. Does nebulized dexamethasone decrease the incidence of postextubation sore throat?: a randomized controlled study. Ains Shams J Anesthiology 9(1):104-7, 2016.
• Results Fitzgerald D, Mellis C, Johnson M, Allen H, Cooper P, Van Asperen P. Nebulized budesonide is as effective as nebulized adrenaline in moderately severe croup. Pediatrics. 1996 May;97(5):722-5.
• Results Klassen TP, Feldman ME, Watters LK, Sutcliffe T, Rowe PC. Nebulized budesonide for children with mild-to-moderate croup. N Engl J Med. 1994 Aug 4;331(5):285-9. doi: 10.1056/NEJM199408043310501.
• Al Atbi AY, Al Khalasi U, Al Atbi A, Al Rawahi S, Al Shaffi K, Al-Mamari S, Al Sakiti M, Al Mujani S, Al Reesi A, Al Shamsi M. Efficacy of nebulized glucocorticoids for acute pharyngitis in an emergency department outpatient population: a multicenter, double-blind, randomized clinical trial. CJEM. 2025 Jul;27(7):543-550. doi: 10.1007/s43678-025-00906-5. Epub 2025 Apr 24.

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Indications