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Comparing the Effects of Two intraNasal drugs in Children Having MRI Scans.

TO COMPARE THE EFFICACY OF INTRANASAL DEXMEDITOMIDINE VERSUS INTRANASAL MIDAZOLAM IN PAEDIATRIC PATIENTS UNDERGOING MRI: A PROSPECTIVE RANDOMIZED DOUBLE BLIND CLINICAL STUDY. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100788
Enrollment
92
Registered
2026-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: B- Imaging

Interventions

Intervention1: intranasal dexmeditomidine: Group D: Intranasal Dexmeditomidine 3 microgram/kg dexmedetomidine Drug will be taken undiluted in 1ml insulin syringe. Equal volume of drug to be insti

Sponsors

Medical College Baroda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pediatrics age group(6months to 8years) 2.either sex 3.ASA grade I ,II,III 4.Children whose guardians have given consent for procedure 5.MRI scaning time less than 60 minute

Exclusion criteria

Exclusion criteria: 1.Known case of hypersensitive reaction to drug in study. 2.Presence of congenital heart disease,pulmonary disease. 3.Recent upper respiratory infection or pneumonia. 4.Facial malformation and anticipatory difficult airway may require tracheal intubation . 5.Nasal malformation including polyps,CSF rhinorrea ,nasal bone fracture,epitaxis etc . 6.Extreme tonsillar hypertropy. 7.Previous history of prolong sedation may requiring assisted airway manipulation or active airway intervention. 8.Head trauma ,increased intracranial tension.

Design outcomes

Primary

MeasureTime frame
To compare quality of sedationTimepoint: BASELINE

Secondary

MeasureTime frame
1)Hemodynamic parameter 2)quality of MRI scanning 3)observed side effect and complication following sedation 4)post procedure discharge scaleTimepoint: starting point to discharge from recovery room

Countries

India

Contacts

Public ContactDr NOOTAN MARU

Goverment medical college Baroda

yogi.80patel@gmail.com9023449878

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026