Dexmedetomidine, Midazolam, MRI, Pediatrics
Conditions
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.
Interventions
DRUGDexmedetomidine
30 children will be sedated with 2 μg/kg intranasal DEX.
DRUGMidazolam
30 children will be sedated with 0.3 mg/kg intranasal midazolam.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Egypt
Outcome results
None listed