Melatonin vs Midazolam in Children Undergoing Tonsillectomy
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Emergence Delirium, Anesthesia, Child, Anxiety, Midazolam Premedication, Melatonin Bioavailability, Tonsillectomy
In brief
Used as a premedication to decrease anxiety (Caumo et al., 2007). Midazolam, though has several drawbacks (McCann and Kain, 2001). Hence, an alternative premedication to midazolam will definitely have a widespread appeal. Melatonin is a hormone secreted by the pineal gland. Melatonin is different from benzodiazepines and their derivatives in that it exerts a promoting effect on sleep by amplifying day/night differences in alertness and sleep quality and displaying a modest sleep-inducing effect, quite mild as compared to that seen with benzodiazepines (Ahmad et al., 2007). Melatonin has also been reported to cause preoperative anxiolysis and an increase in levels of sedation without impairing orientation (Naguib and Samarkandi, 2000). Hence, the aim of this study is to compare the effect of oral melatonin and oral midazolam on preoperative anxiety. Emergence delirium (ED) was first described in the literature in the early 1960s. Although often used interchangeably with emergence agitation, it is defined as a temporary dissociated state of consciousness after discontinuation of anesthesia. The characteristics that make up ED include irritability, inconsolable crying, distress and inability to cooperate (Reduque and Verghese, 2013). Midazolam is the most prescribed oral premedication in the preoperative setting. Its benefits include preoperative anxiolysis, amnesia, relatively rapid onset and short duration of action. Although most children have anxiolysis with midazolam, up to 29% may display a paradoxical agitation response (Shin et al., 2013). Oral melatonin doses up to 0.4 mg/kg (maximum 20 mg) are effective in reducing ED in children (age 3-7 years) (Kain et al., 2009). AIM OF THE WORK The study aims to compare the effects of oral melatonin and oral midazolam on preoperative anxiety as a premedication in children undergoing tonsillectomy.
Key facts
- Study ID
- NCT07336095
- Run by
- Ain Shams University
- People needed
- 195
- Starts
- 2026-03-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-01-13
Who can join
Age: 3 and older, up to 12. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ALL children with ASA class I and class II
You may not qualify if…
- chest infection
- Abnormal mental milestones.
- Children with any organ dysfunction.
- Allergies to any of the drugs used.
- Children with Obstructive sleep apnea.
Full record on ClinicalTrials.gov
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