Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

NCT04652661 | Completed Phase 4

• 1 other identifier: 32466/11/20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.

Conditions

Dexmedetomidine; Midazolam; MRI; Pediatrics

Outcome Measures

Primary Outcomes (1)

• The incidence of successful sedation

  Successful sedation is defined as the time taken to achieve an MOAA/S score of 4 and is the time when the patients are calm and sedated and allow intravenous cannulation and MRI examination without crying or agitation.

  One hour

Secondary Outcomes (3)

• The onset time of sedation

  One hour

• The occurrence of Adverse effects

  One hour

• The degree of operator satisfaction

  One hour

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

30 children will be sedated with 2 μg/kg intranasal dexmedetomidine

Drug: Dexmedetomidine

Midazolam Group

ACTIVE COMPARATOR

30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

30 children will be sedated with 2 μg/kg intranasal DEX.

Dexmedetomidine Group

Midazolam DRUG

30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Midazolam Group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.

You may not qualify if:

• Patient's guardian refusal.
• Body mass index \>30 kg/m2
• Known allergy to dexmedetomidine or midazolam.
• Suspected difficult airway.
• Upper respiratory tract infection
• Anatomical structural deformity of the nasal cavity.
• Severe liver or renal impairment.
• Severe bradycardia or atrioventricular block above II degree type 2.
• Administration of digoxin or beta blockers

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Location

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Model Details: Sixty children will be randomly allocated into two equal groups by computer generated sequence through sealed opaque envelopes: Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: December 10, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)