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Comparative study between two routes of Midazolam administeration for sedation in children.

Comparison between oral midazolam and intranasal midazolam for sedative premedication in paediatric patients. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071230
Enrollment
100
Registered
2024-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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 Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Intranasal Midazolam Spray and Oral Midazolam: Intranasal Midazolam Spray(0.1mL or 0.5mg per spray , 0.2mg/kg) and Oral Midazolam (5mg per mL ampoule, 0.5mg/kg) each for a total duratio

Sponsors

Dr Reem Khatib
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-5 years aged patients of either sex ASA I – II Patients posted for routine paediatric surgeries Hemodynamically stable patients with all routine investigations within normal limits. Patients whose parents or guardians give written informed consent and are willing their child to be a part of the study.

Exclusion criteria

Exclusion criteria: 6 years and above ASA grade 3 and above known allergy to study drugs nasal pathology

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.Timepoint: Five point sedation score followed by parental separation score will be assessed at the end of 20 minutes from administeration of the drug.

Secondary

MeasureTime frame
To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.Timepoint: Acceptance to mask & response to venepuncture will be assessed after 20 minutes of drug administer in the operating room The Modified Alderte score shall be assessed for 30 minutes from extubation in the recovery room

Countries

India

Contacts

Public ContactReem Khatib

Dr D Y Patil Medical College, Hospital and Research Centre

shahbazhsnn@gmail.com9764621253

Outcome results

None listed

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