M R J Sury1, K Fairweather. 1. Department of Anaesthesia, Great Ormond Street Hospital for Children NHS Trust, London, UK. surym@gosh.nhs.uk
Abstract
BACKGROUND:Melatonin may induce a natural sleepiness and improve predictability of sedation drugs. We have investigated its clinical value in children sedated for magnetic resonance imaging. METHODS: In a stratified randomized double-blind study, 98 children received either melatonin or placebo 10 min before they were sedated with a standard oral regimen. Children >5 and <15 kg received chloral hydrate and those >or=15 and <40 kg had a combination of temazepam with droperidol (T&D). The doses of melatonin were 3 and 6 mg, respectively. One observer recorded the time taken to reach criteria for deep sedation, sedation failure and other sedation-related events. RESULTS: In the chloral hydrate group (n=50) 50% were deeply sedated by 31 min after melatonin and 40 min after placebo (P=0.57). There were zero and 1 failures, respectively. The geometric mean time taken to reach deep sedation was 39 min in both subgroups. In the T&D group (n=48) 50% were deeply sedated by 70 min in both subgroups (two failures in each); geometric mean times were 68 and 71 min, respectively (P=0.58). Children closed their eyes slightly earlier after melatonin (respective geometric means 42 vs 48, P=0.17), and took slightly longer to achieve discharge criteria (146 vs 135, P=0.47). CONCLUSION: In these doses and clinical conditions, melatonin did not contribute to sedation of children.
RCT Entities:
BACKGROUND:Melatonin may induce a natural sleepiness and improve predictability of sedation drugs. We have investigated its clinical value in children sedated for magnetic resonance imaging. METHODS: In a stratified randomized double-blind study, 98 children received either melatonin or placebo 10 min before they were sedated with a standard oral regimen. Children >5 and <15 kg received chloral hydrate and those >or=15 and <40 kg had a combination of temazepam with droperidol (T&D). The doses of melatonin were 3 and 6 mg, respectively. One observer recorded the time taken to reach criteria for deep sedation, sedation failure and other sedation-related events. RESULTS: In the chloral hydrate group (n=50) 50% were deeply sedated by 31 min after melatonin and 40 min after placebo (P=0.57). There were zero and 1 failures, respectively. The geometric mean time taken to reach deep sedation was 39 min in both subgroups. In the T&D group (n=48) 50% were deeply sedated by 70 min in both subgroups (two failures in each); geometric mean times were 68 and 71 min, respectively (P=0.58). Children closed their eyes slightly earlier after melatonin (respective geometric means 42 vs 48, P=0.17), and took slightly longer to achieve discharge criteria (146 vs 135, P=0.47). CONCLUSION: In these doses and clinical conditions, melatonin did not contribute to sedation of children.