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NCT Number: NCT04652661

Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

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.

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Key information

Conditions

Dexmedetomidine MRI Midazolam Pediatrics

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

30 children will be sedated with 2 μg/kg intranasal DEX.

midazolam

Drug

30 children will be sedated with 0.3 mg/kg intranasal midazolam.

Primary outcomes

  1. The incidence of successful sedation

    Time frame: 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 outcomes

  1. The onset time of sedation

    Time frame: One hour

    The onset time of sedation is defined as the time from drug administration to successful sedation.

  2. The occurrence of Adverse effects

    Time frame: One hour

    The occurrences of adverse events will be recorded (e.g. bradycardia, a significant oxygen saturation decrease, severe arrhythmia or arrest).

  3. The degree of operator satisfaction

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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