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Comparing inhaled Dexmedetomidine against inhaled Midazolam to suppress anxiety in children.

A comparative evaluation of nebulised Dexmedetomidine versus nebulised Midazolam for parent separation anxiety, mask acceptance and emergence reaction in paediatric population. - NILL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056083
Enrollment
54
Registered
2023-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nebulisation: Nebulisaton will be done 30 minutes prior to surgery. Control Intervention1: Dexmedetomidine.: Patients who are ASA 1 and 2, aged 3-8 years, undergoing elective procedures

Sponsors

Daryl Phils Joe
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA GRADE 1 AND 2 Elective surgeries under general anaesthesia.

Exclusion criteria

Exclusion criteria: Emergency surgeries. Known allergies to dexmedetomidine and/or midazolam. Significant organ dysfunction. Cardiac dysrhythmias, Congenital heart disease. Mentally challenged.

Design outcomes

Primary

MeasureTime frame
Compare parent separation anxiety in paediatric population receiving nebulised dexmedetomidine or nebulised midazolam preoperatively.Timepoint: 30 minutes prior to surgery

Secondary

MeasureTime frame
To compare emergence reaction in paediatric population receiving nebulised dexmedetomidine or nebulised midazolam preoperatively.Timepoint: immediately after surgery to 30 minutes after surgery;To compare mask acceptance in paediatric population receiving nebulised dexmedetomidine or nebulized midazolam preoperativelyTimepoint: On start of anaesthetic procedures.

Countries

India

Contacts

Public ContactDr Apoorwa N Kothari

St Johns Medical College

drapoorwa100@gmail.com9632266777

Outcome results

None listed

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