Herpetic Gingivostomatitis
Conditions
Brief summary
Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this are dehydration, pain and hospitalisation. The objective of this randomized controlled trial is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms associated with acute herpes gingivostomatitis in children. This study will involve 80 children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days. The primary outcome measure will be the duration (in days) of feeding and/or drinking difficulties.
Interventions
DRUGValacyclovir
DRUGplacebo
Sponsors
Canadian Association of Emergency Physicians
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
are : * Children from 10 to 28 Kg of weight. The inclusion of participants is based on weight for practical/feasibility reasons because the study medication will be provided in tablet format. The lower limit of 10 kg is to limit to three strata of weight and limit costs engendered by the preparation of medication. * Clinical diagnosis of herpetic gingivostomatitis according to the treating physician. This is described by the presence of: * Fever (\>38.5° rectal, \>38° oral) AND * Vesicular or ulcerative lesions located in the anterior of the mouth * Associated or not with perioral vesicular lesions Visiting the emergency department within the first 96 hours of the disease begin.
Exclusion criteria
are : * Duration of fever \> 4 days * Hospitalised patients * Immunocompromised patients * Patients with known hypersensitivity to Valacyclovir * Patients with renal failure * Children with complete incapacity of oral treatment intake * Unable to be contacted for phone follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of feeding and/or drinking difficulties | 2 weeks | This will be defined by the number of days until the participants return to normal feeding and eating according to the parents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of fever | 2 weeks | — |
| duration of pain | 2 weeks | — |
| duration of oral lesions | 2 weeks | — |
| global parent satisfaction | 2 weeks | Likert scale on how satisfied the parents are with the medication. This will be measured during a follow-up survey at 7 and 14 days following randomisation |
| duration of school or work absence | 2 weeks | — |
| utilisation of medical resources | 2 weeks | hospitalisation for intra venous hydration, visit to a physician, use of analgesics or other medication. This will be measured during a follow-up survey at 7 and 14 days following randomisation |
| adverse side effects | 2 weks | — |
Countries
Canada
Outcome results
None listed