Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?

St. Justine's Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Herpetic Gingivostomatitis

Interventions

ValacyclovirDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Sainte-Justine

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Duration of feeding and/or drinking difficulties

This will be defined by the number of days until the participants return to normal feeding and eating according to the parents.

Time frame: 2 weeks

Secondary Outcomes

duration of fever

Time frame: 2 weeks

duration of pain

Time frame: 2 weeks

duration of oral lesions

Time frame: 2 weeks

global parent satisfaction

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

Time frame: 2 weeks

duration of school or work absence

Time frame: 2 weeks

utilisation of medical resources

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

Time frame: 2 weeks

adverse side effects

Time frame: 2 weks

Data from ClinicalTrials.gov

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