Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Phase 4

Completed

• Conditions: Midazolam; MRI; Pediatrics; Dexmedetomidine
• Interventions: Drug: Midazolam; Drug: Dexmedetomidine

• Registration Number: NCT04652661
• Lead Sponsor: Tanta University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-03
• Study Start: 2020-12-10
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam Group	Midazolam	30 children will be sedated with 0.3 mg/kg intranasal midazolam.
Dexmedetomidine Group	Dexmedetomidine	30 children will be sedated with 2 μg/kg intranasal dexmedetomidine

Primary Outcome Measures

Name	Time	Method
The incidence of successful sedation	One hour	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.

Secondary Outcome Measures

Name	Time	Method
The onset time of sedation	One hour	The onset time of sedation is defined as the time from drug administration to successful sedation.
The occurrence of Adverse effects	One hour	The occurrences of adverse events will be recorded (e.g. bradycardia, a significant oxygen saturation decrease, severe arrhythmia or arrest).
The degree of operator satisfaction	One hour	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).

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, ElGharbiaa, Egypt