Status:
UNKNOWN
Do We Need to Taper Down Steroid Therapy for Bell's Palsy
Lead Sponsor:
Carmel Medical Center
Conditions:
Bell Palsy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Bell's palsy \[BP\] is defined as acute idiopathic peripheral facial palsy or paralysis. Additional symptoms frequently include pain around or behind the ear, impaired tolerance to ordinary levels of...
Detailed Description
A prospective randomized controlled trial of adult patients diagnosed with BP in the otolaryngology emergency department within 72 hours of symptoms onset. Patients will be randomized to receive one ...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years) diagnosed with BP within 72 hour of onset.
- Adult patients willing to get treatment, attending follow up visits and signing informed consent.
Exclusion
- Patients treated with antivirals (i.e acyclovir) for any reason simultaneously, such as Herpes Zoster (Ramsay- Hunt syndrome).
- Palsy onset \> 72 hours before diagnosis or unknown onset.
- Previous episodes of BP.
- Patients suspected for hypothalamic-pituitary-adrenal (HPA) axis suppression who have to be cautiously tapered due to high risk for adrenal insufficiency: steroid treatment in any dosage for more the 3 weeks (due to other indication) or cushingoid appearance.
- Contraindication for steroid use: uncontrolled diabetes or hypertension, psychosis, peptic ulcer or upper GI bleeding, liver cirrhosis or portal hypertension, known allergy to prednisone, etc. Any case in which steroid treatment was stopped earlier than planned by the patient or the physician.
- Any conditions suspicious for non-idiopathic facial palsy: chronic otitis media, acute otitis media, mastoiditis, temporal bone/middle ear trauma, other cranial nerve neuropathies (i.e cranial nerve VIII), cerebrovascular disorders, tumor affecting facial nerve (i.e, parotid malignancy, schwannoma) or systemic causes (i.e multiple sclerosis, meningitis, sarcoidosis, HIV infection, etc).
- Patients with low compliance for treatment according to the physician.
- Pregnancy or breast-feeding patients.
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04406376
Start Date
May 12 2020
End Date
August 1 2023
Last Update
July 28 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lady Davies Carmel Medical Center. Department of Otolaryngology, Head and Neck Surgery
Haifa, North, Israel, 3436212