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| Name | Class |
|---|---|
| Canadian Association of Emergency Physicians | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valacyclovir | Experimental | Valacyclovir will be given twice a day with following doses according to weight: 10 to 13,9 kg : Valacyclovir 250 mg PO twice per day 14 to 19,9 kg : Valacyclovir 375 mg PO twice per day 20 to 28 kg : Valacyclovir 500 mg PO twice per day |
|
| control | Placebo Comparator | placebo pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valacyclovir | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| duration of fever | 2 weeks | |
| duration of pain | 2 weeks | |
| duration of oral lesions |
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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:
Exclusion criteria are :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte-Justine | Montreal | Quebec | H3T1C5 | Canada |
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| ID | Term |
|---|---|
| D013283 | Stomatitis, Herpetic |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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|
| 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 | 2 weeks |
| duration of school or work absence | 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 | 2 weeks |
| adverse side effects | 2 weks |
| D007239 |
| Infections |
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |