Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

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

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.

Study Overview

• Status: Completed
• Conditions: MRI; Dexmedetomidine; Pediatrics; Midazolam
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • ElGharbiaa
    • Tanta, ElGharbiaa, Egypt, 31527
      • Tanta University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 32466/11/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be provided with a reasonable request from authors

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No