Comparison of three non invasive sleep inducing drugs for MRI photography in childre
Phase 1
Completed
- Conditions
- Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
- Registration Number
- CTRI/2019/01/017257
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 195
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time of onset of sedation, duration of sedation and adverse events following the use of above three drugs <br/ ><br>Timepoint: The duration of sedation will be calculated as the difference between the end and start times. All possible adverse events will be recorded.