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A study to compare the efficacy of midazolam administered in the nose for sedation in children fasting 2 hours versus 1 hour for clear fluids.

Comparison of the efficacy of intranasal midazolam sedation in children fasting 2 hours versus 1 hour for clear fluids- Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083736
Enrollment
58
Registered
2025-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None listed

Interventions

Intervention1: Intranasal midazolam administration done in children fasting 1 hour prior to dental treatment: Fasting regimen followed will be 6 hours for solids 4 hours for breast or formula milk and

Sponsors

Dr Medhashree Tumuluri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged 2-10years for dental extraction. 2. American Association of Anaesthesiologist (ASA) 1 and 2 children. 3. Children with Frankl’s behaviour rating of 2,3 and 4.

Exclusion criteria

Exclusion criteria: 1. Children unwilling to participate in study (not willing/convinced for consumption of clear fluids) 2. Children with a recent history of (within past 14 days) or active upper respiratory tract infection and nasal discharge. 3. Cellulitis and extraoral swelling. 4. Allergy to benzodiazepines. 5. Obese children. 6. Children with enlarged tonsils and history of snoring.

Design outcomes

Primary

MeasureTime frame
To observe the clinical reaction of intranasal midazolam in children fasting 2 hours versus 1 hour for clear fluids at four different time intervals Timepoint: 1.During the administration of drug (baseline) 2.During dental treatment 3.At discharge 4.24hrs post treatment.

Secondary

MeasureTime frame
To rate behaviour of children in both the groups during administration of local anaesthesia and during dental treatment of intranasal midazolam using Venham anxiety/behaviour rating scaleTimepoint: 1. During the administration of drug (baseline) 2. During dental treatment 3. At discharge 4. 24hrs post treatment.

Countries

India

Contacts

Public ContactDr Ashwin Rao

Manipal College of Dental Sciences Mangalore

ashwin.rao@manipal.edu09848392710

Outcome results

None listed

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