A Phase 2/3 interventional study of Melatonin and Midazolam in Comparative Effectiveness, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Prevention
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Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparision between two oral drugs preoperative for pediatrics to reach a result of anxiolysis and decrease separation anexity .
Ain Shams University is the lead sponsor of 1,954 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: oral melatonin
Drug: Melatonin
Drug : oral midazolam
Drug: Midazolam
Child separation behavior
Evaluated using Child-Parent Separation Score of 4 grades, higher score means difficult separation
Time frame: 20 minutes after drug administration
Preoperative anxiety
Measured using Yale preoperative Anxiety scale
Time frame: 20 minutes after drug administration and upon OR arrival
Drug acceptance between melatonin and midazolam
regarding each drug taste, score of 3 which 3 means unpleasant taste
Time frame: baseline, time of oral drug administration
Sedation level
Assesed by University of Michigan sedation scale, score of 4 which 4 means unarousable
Time frame: 20 minutes after drug administration and upon OR arrival
Post operative emergance agitation
Assessed by Richmond Agitation-Sedation Scale ranging from -5 which means unarousable to +4 which means combative
Time frame: Post extubation ranging from immediate post operative extubation to 2 hours postoperative
Post operative emergance delirium
Using Pediatric Anesthesia Emergance Delirium Scale ,ranging from 0 to 20 where 0 eans calm and agitation considered if score more than 10
Time frame: initial assesment ( T0) at the moment of awakening ,, then every 10 minutes for 1 hour
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Melatonin · Midazolam