Table 1.

Inclusion and Exclusion Criteria

Inclusion criteria
1. Be aged from 6 months to less than 18 years of age.
2. Weight ≥5 kg.
3. Be diagnosed with Bell’s palsy by their treating doctor.
4. Have acute onset of symptoms of Bell’s palsy for less than 72 hours prior to randomisation.
5. Have written informed consent provided by the parent(s) or legal guardian. The participant, where he/she is deemed competent to provide consent, may also provide written consent.
Exclusion criteria
1. Likely to be unable to complete the 1 month study assessment of Bell’s palsy symptoms. Where the participant is unable to attend the study site, the assessment can be completed via videoconferencing using skype software or other online tools.
2. Previously randomised into the study.
3. Contraindication to prednisolone, including: active or latent tuberculosis, systemic fungal infection, known hypersensitivity to prednisolone or any of the excipients in the liquid, diminished cardiac function, diabetes mellitus, peptic ulcer or chronic renal failure, multiple sclerosis, recent active herpes zoster or chickenpox.
4. Use of any systemic or inhaled steroid within 2 weeks prior to the onset of symptoms.
5. Current or past oncological diagnosis.
6. Pregnancy.
7. Breast feeding.
8. Currently receiving concomitant medications in which prednisolone is contraindicated.
9. Immunisation with a live vaccine within the previous 1 month.
10. Requirement for a live vaccine within 6 weeks of the first dose of study drug.
11. Signs of upper motor neurone VII nerve palsy (weakness of the lower half of the face only).
12. Diagnosis by a medical doctor of acute otitis media concurrently or within 1 week prior to the onset of Bell’s palsy symptoms.
13. Evidence of vesicles on the ear drum suggestive of herpes zoster related Ramsay Hunt syndrome.
14. Known facial trauma within 1 week prior to the onset of symptoms that in the view of the clinician may have caused or contributed to facial palsy.
15. Any other condition at risk of being influenced by the study treatment or that might affect completion of the study.
16. Any concern regarding parent/guardian/participant ability to comply with the study protocol.
17. Prior episode of Bell’s palsy.