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

NCT06181682 | Unknown Phase 4 FDA Drug

• 1 other identifier: ASU MS
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Onset of sedation

  within 30 minutes after drugs administration

• awakening time

  within 15 minutes after end of anaesthesia

• post-operative emergence delirium and agitation.

  within 30 minutes from recovery

Study Arms (2)

dexmedetomidine group

ACTIVE COMPARATOR

patients will receive intranasal dexmedetomidine (1 microgram/kg) -Intranasal dexmedetomidine will be prepared from the 100 mcg/ml parenteral preparation in a 1-ml syringe, and 0.9% saline will be added to make a final volume of 1 ml- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.

Drug: Dexmedetomidine

midazolam group

ACTIVE COMPARATOR

patients will receive intranasal midazolam (0.2 mg/kg) up to 5 mg - Intranasal midazolam will be prepared from a 5 mg/ml parenteral preparation, and 0.9% saline will be added to make a final volume of one ml in a 1-ml syringe- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Intranasal Dexmedetomidine

Also known as: Precedex

dexmedetomidine group

Midazolam DRUG

Intranasal midazolam

Also known as: Dormicum

midazolam group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

marwa Salem, MD

CONTACT

1003591259; marwamostafa@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12