{"id":"melatonin-in-children-premedication","safety":{"commonSideEffects":[{"rate":null,"effect":"Drowsiness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Melatonin is an endogenous hormone that regulates circadian rhythm and sleep-wake cycles by activating melatonin receptors in the suprachiasmatic nucleus and other brain regions. In the premedication context, it reduces anxiety and promotes sedation in children undergoing anesthesia or medical procedures, offering a non-pharmacological alternative to benzodiazepines with a favorable safety profile.","oneSentence":"Melatonin binds to melatonin receptors (MT1 and MT2) in the brain to promote sleep and reduce anxiety in pediatric patients before medical procedures.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:54:19.767Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Premedication and anxiolysis in children undergoing anesthesia or medical procedures"}]},"trialDetails":[{"nctId":"NCT07336095","phase":"PHASE3","title":"Melatonin vs Midazolam in Children Undergoing Tonsillectomy","status":"NOT_YET_RECRUITING","sponsor":"Ain Shams University","startDate":"2026-03-01","conditions":"Emergence Delirium, Anesthesia, Child, Anxiety","enrollment":195},{"nctId":"NCT06489327","phase":"NA","title":"Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery","status":"RECRUITING","sponsor":"Al-Azhar University","startDate":"2026-07-12","conditions":"Preoperative Anxiety","enrollment":120},{"nctId":"NCT06031961","phase":"NA","title":"The Premedication Properties of Oral Melatonin in Pediatrics Undergoing Therapeutic Cardiac Catheterization","status":"UNKNOWN","sponsor":"Al-Azhar University","startDate":"2023-09-10","conditions":"Anesthesia","enrollment":80},{"nctId":"NCT02265822","phase":"PHASE4","title":"Melatonin Premedication in Children Undergoing Surgery","status":"COMPLETED","sponsor":"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"","startDate":"2012-09","conditions":"Premedication, Anaesthesia","enrollment":92}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"melatonin in children premedication","genericName":"melatonin in children premedication","companyName":"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"","companyId":"azienda-ospedaliera-universitaria-policlinico-g-martino","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Melatonin binds to melatonin receptors (MT1 and MT2) in the brain to promote sleep and reduce anxiety in pediatric patients before medical procedures. Used for Premedication and anxiolysis in children undergoing anesthesia or medical procedures.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}