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Comparison of two drugs for premedication in children planned for MRI

Comparison of clinical outcome of Intranasal Dexmedetomidine versus Intranasal Midazolam as premedication in children undergoing MRI : A Randomised double blind study - MRI

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066613
Enrollment
100
Registered
2024-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G00-G99- Diseases of the nervous system

Interventions

Intervention1: Nil: Nil Control Intervention1: Intranasal Midazolam: Group M will receive Intranasal Midazolam (0.2 mg/kg) 30 mins prior to scan Control Intervention2: Intranasal Dexmedetomidine: Gro

Sponsors

Department of Anesthesia and Pain Medicine Pt JNM Medical College Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA GRADE I AND II BODY WT 10-20 KG SCHEDULED FOR MRI UNDER SEDATION

Exclusion criteria

Exclusion criteria: 1.Not nil by mouth 2.Parents refusal 3.Duration of scan more than 60-90 mins 4 Congenital heart disease, upper respiratory tract infection, 5.Pts. on Antipsychotics, Anticonvulsants, any sedative drugs. 6. Pts with altered sensorium

Design outcomes

Primary

MeasureTime frame
Level of sedation as assessed by OAA/S scale (Observer Assessment of Alertness/Sedation Score)Timepoint: The time of dosage will be noted, and the observer will record SpO2, HR and the sedation level at 5-min intervals for 30min following drug administration.

Secondary

MeasureTime frame
1.Onset of sedation 2. Ease of Parental Separation 3.Changes in Hemodynamic parameters 4.Total dose of requirement of supplemental Fentanyl. Timepoint: The time of dosage will be noted, and the observer will record SpO2, HR at 5-min intervals for 30min following drug administration.

Countries

India

Contacts

Public ContactAnamika Jain

Pt JNM Medical College Raipur

dr.manjutkgh@gmail.com07587351857

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026