Health Condition 1: G00-G99- Diseases of the nervous system
Conditions
Interventions
Intervention1: oral Melatonin: Oral melatonin syrup (0.25 mg per kg up to a maximum of 3
mg for children more than or equal to 15 kg, or up to a maximum of 6 mg for children more than or equal to 15
Sponsors
Government Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children aged 1 to 10 years of either sex 2.American Society of Anaesthesiologists, physical status 1 to 3 3.Scheduled for elective, non contrast brain MRI
Exclusion criteria
Exclusion criteria: 1.Refusal of consent by parents/guardians Recent 2.upper respiratory tract infection (less than 2 weeks) 3.Inadequate fasting status (solids less than 6h, clear fluids less than 2h) 4.Nasal deformity/obstruction (e.g. Choanal atresia) 5.Anticipated difficult airway 6.Significant systemic disease or contraindication to study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of adequate sedation which will be measured as the interval (in minutes) from intranasal dexmedetomidine administration to achievement of a University of Michigan Sedation Scale (UMSS) score more than or equal to 3 in both groups.Timepoint: Time after administration of Intranasal Dexmedetomidine in minutes at which University of Michigan Sedation Scale score more than or equal to 3 achieved. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance during IV cannulation, assessed using the Children s Emotional Manifestation Scale (CEMS) in both groups.Timepoint: After administration of oral Melatonin when the UMSS Score of more than or equal to 3 will be achieved.;Success rate of sedation, proportion of children achieving successful sedation, defined as completion of MRI without intravenous (IV) rescue sedation and maintaining a UMSS of more than or equal to 3 throughout imaging, compared between the two groups.Timepoint: Immediately after completion of MRI;Requirement for rescue sedation, number of patients requiring IV rescue sedation and the total cumulative dose ( g/kg) of rescue sedation administered during MRI, compared between the two groups.Timepoint: During MRI;Movement episodes during MRI via the Movement ScoreTimepoint: During MRI;Monitoring of parameters including HR, NIBP, Oxygen Saturation(baseline,every 5 min)Timepoint: During MRI;Parental satisfaction will be assessed post-procedure using a 5-point Likert Scale in both groups.Timepoint: At the time of discharge;Time to discharge measured as the interval (in minutes) from completion of MRI to achievement of a Modified Aldrete Score more than or equal to 9, compared between the two groups.Timepoint: After completion of MRI;Following Adverse events will be noted: hypotension, bradycardia, desaturation, airway obstruction, prolonged sedation, Emergence agitation/delirium via the Paediatric Anaesthesia Emergence Delirium Scale (PAED) scaleTimepoint: After administration of Oral melatonin, During MRI, After the completion of MRI;Total Sedation Time from UMSS more than or equal to 3 to Modified Aldrete Score more than or equal to 9Timepoint: After administration of the oral Melatonin to before the discharge of the patient;Total hospital stay post-MRITimepoint: After Completion of MRI | — |
Countries
India
Contacts
Public ContactDr Sanjeev Palta
Government Medical College and Hospital, Chandigarh
Outcome results
None listed