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Comparison of three non invasive sleep inducing drugs for MRI photography in children

COMPARISON OF ORAL TRICLOFOS, INTRANASAL MIDAZOLAM AND DEXMEDETOMEDINE FOR SEDATION IN CHILDREN UNDERGOING MRI: AN OPEN LABEL RANDOMIZED CLINICAL TRIAL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017257
Enrollment
237
Registered
2019-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Intranasal Dexmedetomedine 3 mcg/kg, single dose administered as a nasal spray single dose without any repetition: Intranasal Dexmedetomedine 3 mcg/kg, single dose. Compare the efficacy

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 mo-10 yrs with Physical Status 1 and 2 (According to American Society Of Anaesthesiologist grading) requiring Magnetic Resonance Imaging

Exclusion criteria

Exclusion criteria: Patients with h/o allergy to Triclofos, Midazolam and Dexmedetomedine ââ??  Having evidence of upper respiratory tract infection/Nasal obstruction during enrollment ââ??  Epistaxis or acute rhinitis during the time of enrollment ââ??  Severe cardiorespiratory failure ââ??  Difficult airway

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of oral Triclofos, intranasal Midazolam and Dexmedetomedine in achieving successful sedation during MRITimepoint: Paediatric State Sedation Scale assessed every 5 minutes.Typically, a PSSS of less than 4 is considered apt to tolerate diagnostic magnetic resonance imaging studies.

Secondary

MeasureTime frame
Time of onset of sedation, duration of sedation and adverse events following the use of above three drugs Timepoint: The duration of sedation will be calculated as the difference between the end and start times. All possible adverse events will be recorded.

Countries

India

Contacts

Public ContactDr Shyam Chandrasekar

AIIMS Bhubaneswar

dr.dwibedi@gmail.com9337908486

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026