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Comparison of Ease of Administration of nasal Midazolam Spray and Midazolam Syrup by Parents to Children before Surgery

Comparison of Ease of Administration of Intranasal Midazolam Spray and Oral Midazolam Syrup by Parents as Premedication to Children Undergoing Elective Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005449
Enrollment
90
Registered
2015-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Children of age 1 to 6 yrs of ASA physical status 1 and 2 undergoing elective surgical procedures

Interventions

Intervention1: Premedication with intranasal Midazolam spray: Intranasal Midazolam spray at dose of 0.2mg/kg administered by parents in the pre op holding area, half an hour before the patient is shif

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Undergoing Elective surgeries ASA physical status I and II

Exclusion criteria

Exclusion criteria: CNS disorders like epilepsy, pathology with raised ICT, developmental delay, mental retardation. Prolonged therapy with hepatic enzyme inducing drugs Respiratory system dysfunction (rhinorrhea, bronchial asthma, nasal polyps) Cardiac and renal abnormalities Nasal pathology and nasal infections Children with difficult airway and obstructive sleep apnea syndrome Parents who have preference of drug administration via oral or intranasal route

Design outcomes

Primary

MeasureTime frame
To compare the ease of administration of intranasal midazolam spray and oral midazolam syrup by parentsTimepoint: 1.5 yrs—

Secondary

MeasureTime frame
To compare the preoperative separation anxiolysis and sedation of intranasal midazolam and oral midazolam administered by parentsTimepoint: 1.5 years—

Countries

India

Contacts

Public ContactDr Satyaprakash MVS

JIPMER

munaganuri1975@yahoo.co.in9786184626

Outcome results

None listed

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