Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Dexmedetomidine Clinical Trial

Official title:

Intranasal Dexmedetomidine Versus Intranasal Midazolam as Sole Sedative Agents for MRI In Pediatrics: A Randomized Double-Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652661
• Other study ID #: 32466/11/20
• Status: Completed
• Phase: Phase 4
• Start date: December 10, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient's guardian refusal.

2. Body mass index >30 kg/m2

3. Known allergy to dexmedetomidine or midazolam.

4. Suspected difficult airway.

5. Upper respiratory tract infection

6. Anatomical structural deformity of the nasal cavity.

7. Severe liver or renal impairment.

8. Severe bradycardia or atrioventricular block above II degree type 2.

9. Administration of digoxin or beta blockers

Related Conditions & MeSH terms

• Dexmedetomidine
• Midazolam
• MRI
• Pediatrics

Intervention

Drug:
• Dexmedetomidine
30 children will be sedated with 2 µg/kg intranasal DEX.
• Midazolam
30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The onset time of sedation	The onset time of sedation is defined as the time from drug administration to successful sedation.	One hour
Secondary	The occurrence of Adverse effects	The occurrences of adverse events will be recorded (e.g. bradycardia, a significant oxygen saturation decrease, severe arrhythmia or arrest).	One hour
Secondary	The degree of operator satisfaction	MRI operator satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied).	One hour