Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial

Area of Science:

• Pediatric Neurology
• Clinical Trials
• Pharmacology

Background:

• Bell's palsy, or acute idiopathic lower motor neurone facial paralysis, causes sudden facial muscle weakness.
• High-level evidence supports steroid use in adults for Bell's palsy recovery.
• Limited high-level studies exist on steroid efficacy for Bell's palsy in children.

Purpose of the Study:

• To assess the utility and efficacy of steroid treatment in pediatric Bell's palsy.
• To conduct a randomized placebo-controlled trial for children diagnosed with Bell's palsy.

Main Methods:

• A randomized, triple-blinded, placebo-controlled trial involving 540 participants aged 6 months to 18 years.
• Participants presented within 72 hours of Bell's palsy onset and received either prednisolone or placebo for 10 days.
• Primary outcome measured complete facial nerve function recovery at 1 month using the House-Brackmann scale.

Main Results:

• The trial is designed to definitively assess prednisolone's efficacy against placebo.
• Data analysis will use intention-to-treat principles.
• Secondary outcomes include various recovery scales, quality of life, pain, and healthcare costs.

Conclusions:

• This large multicenter trial aims to provide definitive evidence on steroid treatment for Bell's palsy in children.
• Results will inform clinical guidelines for pediatric facial nerve paralysis management.