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Comparision of oral and intranasal routes for midazolam premedication in paediatric patients

Comparision of two routes for midazolam premedication - oral and intranasal in paediatric patients - A prospective observational clinical study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/055961
Enrollment
76
Registered
2023-08-01
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: Nil: Nil

Sponsors

Shaji P John
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Paediatric patients aged between 1-10 years scheduled for elective surgeries. American Society of Anaesthesiologist (ASA) grade 1 and 2.

Exclusion criteria

Exclusion criteria: Children with central nervous system disorder, epilepsy, developmental delay, mental retardation. Known hypersensitivity and contraindication to drugs used. History of significant cardiac, respiratory, renal, hepatic disease. Patients having nasal infection, nasal pathology and taking any other sedative drugs. Parental refusal. Anticipated difficult airway.

Design outcomes

Primary

MeasureTime frame
To find out the level of sedation (sedation score) & acceptance of the route of administration of the drug between the two groups. To find out the ease of parental separation (separation score) between the two groups.Timepoint: Grades of sedation at - 0 mins 5 mins 15 mins 20 mins

Secondary

MeasureTime frame
To assess hemodynamic stability, recovery characteristics (recovery score) & time taken to achieve satisfactory sedation between the two groups.Timepoint: Present or not present

Countries

India

Contacts

Public ContactChristine Shaji John

K S Hegde Medical Academy

shetty.anil10@gmail.com9448012303

Outcome results

None listed

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