Melatonin and intravenous midazolam administered orally in drug induced sleep electroencephalography of children: randomized clinical trial of efficacy.

BACKGROUND: Electroencephalography (EEG) is a useful diagnostic tool in the diagnosis of seizure and differentiating it from seizure-like attacks. Cooperation and immobility of the patient is crucial and in children who do not naturally sleep, pharmacological agents and procedural sedation should be used for sleep inducement. The purpose of this study was to compare efficacy and safety of melatonin and intravenous solution of midazolam administered orally in sedation induction for EEG of children. METHODS: In a parallel single-blinded randomized clinical trial, sixty 1 - 8 year old children who were referred to EEG Unit of Shahid Sadoughi Hospital, Yazd, Iran from September 2011 to March 2012 were evaluated. The Children were randomly assigned into two groups to receive orally 0.3 mg/kg melatonin or 0.75 mg/kg ampoule of midazolam. The primary outcome was efficacy in adequate sedation (Ramsay sedation score of four) and recording of EEG. Secondary outcome was clinical side effects. RESULTS: Nineteen girls (31.7%) and 41 boys (68.3%) with the mean age of 2.8 ± 1.8 years were evaluated. Adequate  sedation  and  recording  of EEG was  achieved in  36.7% of  midazolam  group and  in 73.3%  of  melatonin group, (p = 0.004). Transient agitation was seen in 6.6% of midazolam group. No significant difference was observed from the viewpoint of side effects frequency between the two drugs, (p = 0.15). CONCULSION:   Melatonin is a safe and an effective drug in sedation induction for EEG in children.

Efficacy of chloral hydrate-hydroxyzine and chloral hydrate-midazolam in pediatric magnetic resonance imaging sedation.

OBJECTIVE: Magnetic resonance imaging (MRI) is a useful diagnostic tool for the evaluation of congenital or acquired brain lesions. But, in all of less than 8-year-old children, pharmacological agents and procedural sedation should be used to induce motionless conditions for imaging studies. The purpose of this study was to compare the efficacy and safety of combination of chloral hydrate-hydroxyzine (CH+H) and chloral hydrate-midazolam (CH+M) in pediatric MRI sedation. MATERIALS & METHODS: In a parallel single-blinded randomized clinical trial, sixty 1-7-year-old children who underwent brain MRI, were randomly assigned to receive chloral hydrate in a minimum dosage of 40 mg/kg in combination with either 2 mg/kg of hydroxyzine or 0.5 mg/kg of midazolam. The primary outcomes were efficacy of adequate sedation (Ramsay sedation score of five) and completion of MRI examination. The secondary outcome was clinical side-effects. RESULTS: Twenty-eight girls (46.7%) and 32 boys (53.3%) with the mean age of 2.72±1.58 years were studied. Adequate sedation and completion of MRI were achieved in 76.7% of CH+H group. Mild and transient clinical side-effects, such as vomiting of one child in each group and agitation in 2 (6.6 %) children of CH+M group, were also seen. The adverse events were more frequent in CH+M group. CONCLUSION: Combinations of chloral hydrate-hydroxyzine and chloral hydrate-midazolam were effective in pediatric MRI sedation; however, chloral hydrate-hydroxyzine was safer.

Oral chloral hydrate vs. intranasal midazolam for sedation during computerized tomography.

We conducted this single blind randomized clinical trial to compare the efficacy and safety of oral chloral hydrate and intranasal midazolam for induction of sedation for computerized tomography scan of brain in children. Participants aged 1-10 years (n=60) were randomized to receive 100 mg/kg chloral hydrate orally with intra nasal normal saline OR intranasal midazolam 0.2 mg/kg with oral normal saline. Adequate sedation (Ramsay sedation score of four) was obtained and CT scan completed successfully in 76.7% of chloral hydrate group and in 40% of midazolam group (P=0.004). No significant difference was seen for side effects frequency between the two drugs (10% in chloral hydrate, 3.3% in midazolam group; P=0.34). We conclude that oral chloral hydrate can be considered as a safe and effective drug for sedation in children undergoing CT scan of brain.