Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04652661

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dexmedetomidine Midazolam MRI Pediatrics	Drug: Dexmedetomidine Drug: Midazolam	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 10, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 10, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospitals	Tanta	ElGharbiaa	Egypt	31527

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taysser Mahmoud Abdalraheem, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University

ClinicalTrials.gov Identifier:

NCT04652661

Other Study ID Numbers:

32466/11/20

First Posted:

Dec 3, 2020

Last Update Posted:

Apr 27, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Midazolam

Dexmedetomidine

Study Results

No Results Posted as of Apr 27, 2021