Comparison of two sedative agents in relation to safety in children.

Comparison of intranasal midazolam and inhalation nitrous oxide sedation in relation to safety and physiological effects in children.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021381

Enrollment

Registered

2019-09-23

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: - Health Condition 2: 3- Administration

Interventions

Intervention1: intranasal midazolam: frequency:once at the start of procedure Route: intranasal Duration: the effect prolongs for about 1-2 hours Control Intervention1: inhalation nitrous oxide: frequ

Eligibility

Inclusion criteria

Inclusion criteria: Anxious children requiring pulp therapy

Exclusion criteria

Exclusion criteria: respiratory disorders, previous medication with erythromycin and/or anticonvulsant

Design outcomes

Primary

Measure	Time frame
onset of sedation level of sedation physiological parameters at different stages of the procedure safety scale recovery timeTimepoint: Starting at the beginning of the sedation procedure till the end of the sedation procedure,vitals will be monitored- approximately 30 to 45 minutes depending on the severity of the case	—

Secondary

Measure	Time frame
Recovery timeTimepoint: at the end of the sedation procedure i.e., after 30 to 45 from the start of the procedure	—

Countries

India

Contacts

Public ContactDrSujatha Somasundaram

Saveetha dental college and hospitals

drsujatha.sdc865@gmail.com

Outcome results

None listed

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