Bell's Palsy in Children: A Multi-centre, double-blind, Randomised, Placebo-controlled Trial to Determine Whether Prednisolone Improves Recovery at 1 Month.
A multi-centre randomised controlled trial of children aged between 6 months and 18 years presenting to emergency departments with symptoms of Bell's palsy, to determine whether treatment with oral prednisolone versus a placebo, increases the proportion of children who have complete recovery at 1 month, where complete recovery is defined as grade 1 on the House Brackmann scale.
Franz Babl
540 participants
Oct 13, 2015
Interventional
Conditions
Summary
Children diagnosed with Bell's palsy have a sudden weakness of facial muscles on one side of their face. Bell's palsy usually improves in children in about four to six weeks without treatment. However, in some children it may be a year before the facial weakness has completely resoved and in a small number of cases, the facial muscle weakness is permanent. Recent research in adults with Bell's palsy has shown that a short course of treamtent with steroids (prednisolone) led to improved recovery time. Prednisolone is believed to reduce the irritation to the facial nerve. There are no similar studies in children and, because children's bodies respond different to adults', it is not known whether a short course of prednisolone will help children to recover more quickly. Currently, some doctors treat with prednisolone and others do not resulting in confusion and variability in medical care. The study aims to answer the following question: In children presenting to Emergency Departments with recent onset of Bell's palsy, does treatment with prednisolone result in a higher proportion of children with recovery at 1 month compared with placebo. Up to 13 hospitals in Australia and New Zealand will participate in enrolling 540 children/young people, aged 6 months to 18 years, who present to ED's within 72 hours of symptom onset.
Eligibility
Inclusion Criteria1
- Patients must be aged between 6 months to less than 18 years, weigh greater than or equal to 5kg, be diagnosed with Bell's Palsy by their treating doctor and have an acute onset of symptoms of Bell's palsy for less than 72 hours prior to randomisation
Exclusion Criteria17
- Previous episode of Bell's Palsy or previously randomised in BellPIC study
- Contraindication to prednisolone: active or latent tuberculosis, systemic fungal infection, known hypersensitivity to prednisolone, diminished cardiac function, diabetes mellitus, peptic ulcer or chronic renal function, multiple sclerosis or recent active herpes zoster or chickenpox
- current use of systemic or inhaled steroid, or use within 2 weeks prior to the onset symptoms
- current or past oncological diagnosis
- FBE result (if obtained during this illness) may indicate leukaemia
- Pregnancy and/or lactating
- Currently receiving medications for which prednisolone is contraindicated
- Immunisation with a live vaccine within the previous 1 month
- Requirement for live vaccine within 6 weeks of first dose of prednisolone
- Signs of upper motor neuron VII nerve palsy (weakness of lower half of the face only)
- Current or recent (1 week prior to Bell's palsy symptoms) otitis media
- Evidence of vesicles on the ear from or vesicles/ulcers elsewhere on the body suggestive of recent herpes simplex, herpes zoster or chickenpox
- Known significant facial trauma within 1 week prior to symptoms appearing
- Referred to GP clinic in Emergency Department or failed to wait
- Unable to attend a follow up visit in one month time
- Any other condition at risk of being influenced by study treatment or completion of study
- Parents will not be able to comply with the study, or have enough understanding of the study.
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Interventions
Intervention: Prednisolone. Prednisolone is a corticosteroid that has strong evidence for effectiveness in reducing the length of facial palsy symptoms in adults suffering from Bell's palsy. Participants assigned to the intervention will receive 1mg/kg/day of prednisolone (dosing is based on weight categories) up to a maximum of 50mg/day for 10 days. The prednisolone will be administered as an oral solution as a once daily dose. Strategies used to monitor adherence will be a survey relating to compliance at the end of the 10 day course of treatment, in addition to the return of the bottles.
Locations(9)
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ACTRN12615000563561