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Is 3 mcg/kg intranasal dexmedetomidine more effective for sedation in children undergoing MRI scan

Comparative evaluation of two different doses of intranasal Dexmedetomidine for sedation in Children undergoing MRI scan - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066593
Enrollment
84
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: G809- Cerebral palsy, unspecified Health Condition 2: P00-P96- Certain conditions originating in the perinatal period Health Condition 3: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities Health Condition 4: I00-I99- Diseases of the circulatory system Health Condition 5: H60-H95- Diseases of the ear and mastoid process Health Condition 6: L00-L99- Diseases of the skin and subcutaneous tissue Health Condition 7: D499- Neoplasm of unspecified behavio

Interventions

Intervention1: Dexmedetomidine 2mcg/Kg and 3mcg/Kg IV: Dexmedetomidine 2mcg/Kg and 3mcg/Kg IV respectively to each group for sedation before shifting to MRI suite. Dexmedetomedine (100mg/ml) will be a

Sponsors

Vardhman Mahavir Medical College and Safdurjung hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: belonging to ASA I and ASA II who are undergoing MRI as outpatients.

Exclusion criteria

Exclusion criteria: 1. Children with active upper respiratory infection or nasal pathology. 2.Risk of difficult intubation. 3.Hypersensitivity or allergy to drugs used in the study.

Design outcomes

Primary

MeasureTime frame
To compare the number of children requiring rescue sedation between the two groups of 2mcg/kg and 3mcg/kg using intranasal dexmedetomidine for MRI scanTimepoint: 45 minutes after administering drug

Secondary

MeasureTime frame
Compare recovery time from sedation using Modified Ramsay Sedation scoreTimepoint: Time taken to reach MRSS 2 from MRSS 5;Compare time of onset of sedation using Modified Ramsay Sedation ScoreTimepoint: Every 5 minutes after administering drug;Duration of seadtion using Modified Ramsay Sedation ScoreTimepoint: Every 5 minutes after administering drug;To compare Parental separation scores using Liekert scoreTimepoint: At 45 minutes after administering drug

Countries

India

Contacts

Public ContactDr Ameeta Sahni

Vardhman Mahavir Medical Collegeand Safdurjung hospital

ameetaas@yahoo.com9811201585

Outcome results

None listed

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