Objectives: Efficacy of oral diazepam in Frequency, severity and duration reduction due to bruxism in children, Isfahan, 2014/2015.
Design: Bruxism is a common childhood problem woreldwide. There is no effective therapy of the disorder in the literature. So we decide to evaluate the efficacy of the drug in 90 otherwise healthy children in age of 2-15 years in a triple blind clinical trial.
Setting and conduct: Enrolled children are divided to three groups as low dose diazepam, high dose diazepam and placebo. The drugs are blindly packed in different colors for age groups of 2-8 and 8-15 year. For age group of 2-8 years 2.5 mg Diazepam(code A- half a 5 mg pill) is considered as low dose, 5 mg Diazepam( code B- half a 10 mg pill) as high dose, and half an identical placebo pill( code c-) as a placebo drug. For age group of 8-15 years 5 mg Diazepam(code A- 5 mg pill) is considered as low dose, 10 mg Diazepam( code B- 10 mg pill) as high dose, and an identical placebo pill ( code C-) as a placebo drug.
The researcher will assess inclusion criteria and include the children in the study.
Each participant will receive 10 drug and advise to consume before bed for 5 nights and then as alternate night for 10 days.
After that, we will follow up patients during 2 weeks, 1months and 3months in order to check symptoms severity, possible adverse effects and consumption/avoiding the consumption of the drug. Data will be analyzed by SPSS
Inclusion criteria including: Bruxism reported by parents; No previous seizure disorder or abnormal movement during sleep; Age 2-15 years; Not taking any medications that affects the neuromuscular system, such as anticonvulsants, benzodiazepines, muscle relaxant and antidepressants; Visual Analogue Score (VAS) will be calculated for included patients by the score of duration, intensity and frequency of bruxism episodes.
Exclusion criteria including: Inability to take a pill; Drug hypersensivity.
Interventions:
For age group of 2-8 years 2.5 mg Diazepam(code A- half a 5 mg pill) is considered as low dose, 5 mg Diazepam( code B- half a 10 mg pill) as high dose, and half an identical placebo pill( code c-) as a placebo drug. For age group of 8-15 years 5 mg Diazepam(code A- 5 mg pill) is considered as low dose, 10 mg Diazepam( code B- 10 mg pill) as high dose, and an identical placebo pill ( code C-) as a placebo drug.
Each participant will receive 10 drug and advise to consume before bed for 5 nights and then as alternate night for 10 days.
Main outcome measures: Intensity, Frequency.