Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy

Anesthesia Clinical Trial

Official title:

Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06181682
• Other study ID #: ASU MS
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2024
• Est. completion date: March 2024

Study information

• Verified date: December 2023
• Source: Ain Shams University
• Contact: marwa Salem, MD
• Phone: 1003591259
• Email: marwamostafa[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

compare the effectiveness of intranasal dexmedetomidine and midazolam as a premedication in sedation of preschool children in GI endoscopy

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• Children of preschool age (2-6 years old).

• American scocity of anaesthesiology (ASA) I - II children.

• Expected duration of the procedure is less than 50 minutes.

Exclusion Criteria:

• Cardiac arrhythmia, congenital heart disease, or hemodynamic or respiratory instability; children at risk for airway obstruction.

• Behavioral, mental or developmental abnormality (example: mental retardation, Attention Deficit Hyperactivity Disorder "ADHD", Autism, Down syndrome).

• Regular intake of either brain stimulant or depressive drugs (example:

Methylphenidate, amphetamine-dextroamphetamine and diazepam respectively).

• Parent's refusal.

• Emergency case.

• Allergy to any of the used drugs

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Dexmedetomidine
Intranasal Dexmedetomidine
• Midazolam
Intranasal midazolam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation status at separation from the parent	Parental separation anxiety scale (PSAS) ,A score of 1-2 was considered "satisfactory separation" and a score of 3-4 was considered "unsatisfactory separation."	within 30 minutes after drugs administration
Secondary	Onset of sedation	Onset of sedation will be recorded according to Modified RAMSAY Sedation Scale when the score reaches 3 points, patient is then ready to be transferred.	within 30 minutes after drugs administration
Secondary	awakening time	recovery time (defined as return of consciousness, recovery of protective air way reflexes and resumption of motor activity)	within 15 minutes after end of anaesthesia
Secondary	post-operative emergence delirium and agitation.	(PAED) scale: Pediatric Anesthesia Emergence Delirium (PAED) scales. scale from 0 to 20. higher scores mean a worse outcome	within 30 minutes from recovery