Understanding of the effect of midazolam with nitrous oxide-oxygen compared to dexmedetomidine with nitrous oxide-oxygen in pediatric dentistry-a clinical trial

comparative evaluation of the efficacy of midazolam - nitrous oxide/oxygen and dexmedetomidine - nitrous oxide/oxygen in pediatric dental procedures: a prospective single-blinded cross over study. - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105252

Enrollment

Registered

2026-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

None listed

Interventions

Intervention1: comparative evaluation of midazolam: Behaviour, sedative effect, hemodynamic variables at a dose of .5 mg/ml Control Intervention1: Intranasal dexmedetomidine: behaviour sedative effect

Eligibility

Inclusion criteria

Inclusion criteria: ASA category 1 childs weight within normal range frankl positive or negative behaviour children with atleast 2 carious lesions

Exclusion criteria

Exclusion criteria: children with identifiable risk factors for airway obstruction, such as enlarged tonsils, or adenoids, nasal polyps, septal deviation and a Mallampati score of 3 or 4

Design outcomes

Primary

Measure	Time frame
houpt scale, ramsay sedation scale, aldrete score, frankls behaviour rating scale, hemodynamic parametersTimepoint: hemodynamic parameters at baseline and every 15 minutes until the procedure ends	—

Secondary

Measure	Time frame
to compare the amnestic effect between oral midazolam with nitrous oxide- oxygen & intranasal dexmedetomidine with nitrous oxide- oxygen using the amnesia testTimepoint: At baseline & 15 minutes after administration of the drug	—

Countries

India

Contacts

Public Contactpooja nellore

mcods mangalore

poojanellore94@gmail.com6304717894

Outcome results