FindTrial
Sign In

To compare three transmucosal routes of midazolam which is a drug that causes conscious sedation helps in reducing anxiety among 3-6 year old children during dental treatment

Comparative Evaluation of Three Transmucosal Routes of Midazolam Administration on Anxiolysis among 3-6 year old children - midazolam

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108021
Enrollment
75
Registered
2026-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

None listed

Interventions

Intervention1: Midazolam administration comparator : intranasal administration: Child s acceptance towards each route of midazolam will be recorded by Venham s Behaviour Rating Scale . The efficacy o

Sponsors

Dr Isha Tewary
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children with Frankl s behaviour rating 2,3(F2) & (F3) 2. Children undergoing invasive procedures (extraction, pulp therapy)

Exclusion criteria

Exclusion criteria: a. Children with Frankl s Behaviour rating 4.( F4) b. Children whose parents would not give consent for the procedure. c. Children under 10kg body weight . d. Children allergic to Benzodiazepines . e. Children suffering from Neuromuscular disease f. Children with obstructive sleep apnea g. Children with liver and hepatic dysfunction h. Child s weight above 25kgs (obese child)

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of Intranasal, Buccal and Sublingual route of Midazolam administration in management of anxiety among 3-6 year old children.Timepoint: 1.To evaluate the effectiveness of Intranasal, Buccal and Sublingual route of Midazolam administration in management of anxiety among 3-6 year old children.—

Secondary

MeasureTime frame
To compare the effectiveness of Intranasal, Buccal and Sublingual route of Midazolam administration in management of anxiety among 3-6 year old children.Timepoint: To compare the effectiveness of Intranasal, Buccal and Sublingual route of Midazolam administration in management of anxiety among 3-6 year old children.—

Countries

India

Contacts

Public ContactDr. Isha Tewary

Kalinga Institute of Dental Sciences

pv.samir@kids.ac.in9938938892

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026