Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-17
SponsorDalarna County Council, Sweden
About this trial
Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in children.
Investigators will perform a double-blind randomized placebo-controlled multicenter trial on children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12 study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10 days (or placebo) will be started on admission. Clinical data, including recovery will be followed-up until 12 months.
The primary outcome is defined as total recovery of the facial nerve palsy, measured with the House-Brackmann scale (grade 1) at 12-months follow-up.
The overall purpose is to assess the utility of cortisone treatment given to children with acute facial nerve palsy in this study. If the total recovery rate is significantly improved in the prednisolone group as compared to the placebo group, prednisolone treatment will be introduced in clinical practice for children with acute facial nerve palsy in order to reduce the risk of persistent symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1-17 years of age
Acute peripheral unilateral facial nerve palsy
Less than 72 hours since debut of symptoms
Signed informed consent
Disqualifiers
Head trauma <1 month
Central or bilateral facial nerve palsy
Malformations in head and neck
Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
Trial design
Design model
Parallel
Treatments tested in this trial
Prednisolone
DrugPrednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
Placebo Oral Tablet
DrugPlacebo tablets with identical appearance to the experimental drug
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: PrednisoloneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
House-Brackmann scale
Total recovery in the two treatment groups measured with the House-Brackmann scale. The House-Brackmann scale (I is normal function and VI is total loss of function) is chosen as primary outcome measure since it is an objective instrument, easy to perform and the one most frequently used in previous studies. The time point 12 months for evaluation of total recovery is chosen as no further improvement of the facial nerve function is expected after 12 months.
Time frame
At 12 months (+/- 2 weeks) after inclusionSecondary outcomes
1
Sunnybrook facial grading system
Total recovery in the two treatment groups measured with the Sunnybrook scale. The Sunnybrook scale (100 is normal function and 0 is total loss of function) is another objective scale for grading the facial nerve function. It will be used as secondary outcome measure. It is easy to perform and has been used in previous studies in children. It correlates well to the House-Brackmann scale.
Time frame
At 12 months (+/- 2 weeks) after inclusion2
Facial Disability Index (FDI)
Disease-specific Quality-of-Life assessment scale, with 5 functional domains (5 means no probelms and 2 or 1 means problems all the time) and 5 social domains (6 means problems all the time and 1 means no problems at all)
Time frame
At 12 months (+/- 2 weeks) after inclusion3
Facial Clinimetric Evaluation (FaCE) Scale
Disease-specific Quality-of-Life assessment scale, with 15 functional and social domains (1 means problems all the time and 5 means no problems at all).
Time frame
At 12 months (+/- 2 weeks) after inclusion4
Synkinesis Assessment Questionnaire (SAQ)
Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time).
Time frame
At 12 month (+/- 2 weeks) after inclusionOther outcomes
1
Adverse events
Number of Adverse Events possibly or probably related to the study drug.
Time frame
Up to 12 month (+/- 2 weeks) after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dalarna County Council, Sweden
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov