Melatonin and intravenous midazolam administered orally in drug induced sleep electroencephalography of children: randomized clinical trial of efficacy.
Study Goal
The researchers aimed to compare the efficacy and safety of melatonin versus midazolam for sedation induction in children undergoing EEG.
Results Summary
Melatonin was significantly more effective than midazolam in achieving adequate sedation (73.3% vs. 36.7%) with no significant difference in side effects. Transient agitation was noted in 6.6% of the midazolam group.
Population
Children aged 1-8 years referred for EEG in a hospital setting.
Effective Dosage
0.3 mg/kg melatonin administered orally.
Duration
Single administration for EEG procedure.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin | increase | adequate sedation and recording of EEG | 1 - 8 year old children referred to EEG Unit | 73.3% | achieved adequate sedation and recording of EEG in | #1 |
midazolam | increase | adequate sedation and recording of EEG | 1 - 8 year old children referred to EEG Unit | 36.7% | achieved adequate sedation and recording of EEG in | #2 |
midazolam | increase | transient agitation | 1 - 8 year old children referred to EEG Unit | 6.6% | transient agitation was seen in | #3 |
melatonin | no change | side effects frequency | 1 - 8 year old children referred to EEG Unit | no significant difference | No significant difference was observed from the viewpoint of side effects frequency between the two drugs | #4 |
midazolam | no change | side effects frequency | 1 - 8 year old children referred to EEG Unit | no significant difference | No significant difference was observed from the viewpoint of side effects frequency between the two drugs | #5 |
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.