Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489327
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-22
Brief Title:
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery A Double-Blind Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Preoperative anxiety is a common issue in pediatric anesthesia Children often experience anxiety and uneasiness due to uncertain outcomes Surgery and anesthesia are among the most traumatic experiences for children often considered anxiety-inducing medical treatments Because they lack control over their environment and circumstances children undergoing medical procedures typically experience significant unease or anxiety Several studies have reported that 50-80 of children experience preoperative anxiety
In order to reduce kids anxiety intensity several measures are utilized These strategies are either pharmacological psychological or behavioural Benzodiazepines are popular drugs that can reduce anxiety in children The most used one in premedication is midazolam It is a rapid-acting benzodiazepine that has a short elimination half-life It has sedative anxiolytic hypnotic and anterograde amnesic effects Midazolam on the other hand might have a number of negative consequences including paradoxical reactions interactions with opioids excessive sedation disorientation and reduced psychomotor performance
Melatonin enhances anti-nociceptive effects most prominently through the modulation of MT1MT2 receptors in the brain and spinal cord In addition it has been demonstrated that melatonin can interact with additional receptors including those in the GABAergic system the nitric oxide NOarginine route the N-Methyl-D-aspartate NMDA system and the dopaminergic system to produce anti-nociceptive and anti-allodynic effects
In order to reduce kids anxiety intensity several measures are utilized These strategies are either pharmacological psychological or behavioural Benzodiazepines are popular drugs that can reduce anxiety in children The most used one in premedication is midazolam It is a rapid-acting benzodiazepine that has a short elimination half-life It has sedative anxiolytic hypnotic and anterograde amnesic effects Midazolam on the other hand might have a number of negative consequences including paradoxical reactions interactions with opioids excessive sedation disorientation and reduced psychomotor performance
Melatonin enhances anti-nociceptive effects most prominently through the modulation of MT1MT2 receptors in the brain and spinal cord In addition it has been demonstrated that melatonin can interact with additional receptors including those in the GABAergic system the nitric oxide NOarginine route the N-Methyl-D-aspartate NMDA system and the dopaminergic system to produce anti-nociceptive and anti-allodynic effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None