Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dexmedetomidine, Midazolam, MRI, Pediatrics

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine Group<br>30 children will be sedated with 2 μg/kg intranasal dexmedetomidine | Drug: Dexmedetomidine<br>* 30 children will be sedated with 2 μg/kg intranasal DEX.<br>|
| Active Comparator: Midazolam Group<br>30 children will be sedated with 0.3 mg/kg intranasal midazolam. | Drug: Midazolam<br>* 30 children will be sedated with 0.3 mg/kg intranasal midazolam.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The onset time of sedation | The onset time of sedation is defined as the time from drug administration to successful sedation. | One hour | 
| 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 | 
| 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 |