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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06181682

Enrollment

Registered

2023-12-26

Start date

2024-01-31

Completion date

2024-03-31

Last updated

2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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

Interventions

DRUGDexmedetomidine

Intranasal Dexmedetomidine

DRUGMidazolam

Intranasal midazolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Sedation status at separation from the parent	within 30 minutes after drugs administration	Parental separation anxiety scale (PSAS) ,A score of 1-2 was considered satisfactory separation and a score of 3-4 was considered unsatisfactory separation.

Secondary

Measure	Time frame	Description
Onset of sedation	within 30 minutes after drugs administration	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.
awakening time	within 15 minutes after end of anaesthesia	recovery time (defined as return of consciousness, recovery of protective air way reflexes and resumption of motor activity)
post-operative emergence delirium and agitation.	within 30 minutes from recovery	(PAED) scale: Pediatric Anesthesia Emergence Delirium (PAED) scales. scale from 0 to 20. higher scores mean a worse outcome

Contacts

Primary Contactmarwa Salem, MD

marwamostafa@med.asu.edu.eg1003591259

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026