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A Comparative study to assess the efficacy of atomized versus drops administration of intra nasal midazolam as premedication in pediatric patients undergoing elective surgery under general anesthesia

A Comparative study to assess the efficacy of atomized versus drops administration of intra nasal midazolam as premedication in pediatric patients undergoing elective surgery under general anesthesia – A prospective randomized double blind study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077237
Enrollment
60
Registered
2024-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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: GROUP M: 0.3mg/kg of midazolam delivered by Mucosal Atomization Device in 30 patients. Control Intervention1: Midazolam delivered by Syringe dropper: 0.3mg/kg of midazolam delivered by

Sponsors

S D M College Of Medical Sciences And Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to be part of study 2. Patient with Physical status ASA 1 and 2 3. Patients of either sex, age between 2 years to 6 years of age 4. Patients posted for elective surgery

Exclusion criteria

Exclusion criteria: 1. Patients with nasal pathology 2. Patients allergic to drugs used in study 3. Patients with significant organ dysfunction 4. Patients with mental retardation.

Design outcomes

Primary

MeasureTime frame
The aim of this study is to compare the efficacy of mucosal atomization device compared to syringe dropper in terms of sedation score at the end of 30 minutes after drug delivery.Timepoint: At 5,10,20,30 minutes after intervention—

Secondary

MeasureTime frame
To observe for device acceptance, occurrence of adverse effects of the procedure and anxiolysis at the time of shifting the patient.Timepoint: At 5,10,20,30 minutes after intervention—

Countries

India

Contacts

Public ContactDr Imran Sholapur

S D M COLLEGE OF MEDICAL SCIENCES AND HOSPITAL

drimransholapur@gmail.com9731047204

Outcome results

None listed

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