To compare Melatonin given orally and Midazolam given intranasally to check anxiety of pediatric patients during extraction of teeth.

Effect of Intranasal Midazolam and Oral Melatonin in anxious children during dental procedure - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087870

Enrollment

Registered

2025-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: F409- Phobic anxiety disorder, unspecified

Interventions

Intervention1: Melatonin: 0.5 mg/ kg body weight orally before start of the procedure. Control Intervention1: Intranasal Midazolam Nasal Spray (Dosage - 0.5 mg/ kg body weight): After sedation is achi

Eligibility

Inclusion criteria

Inclusion criteria: Children requiring Extraction of primary teeth will be randomly selected from the outpatient department. Children having physical status of ASA I type. Age group between 8 to 12. Frankel behaviour rating 2 or 3.

Exclusion criteria

Exclusion criteria: Children is a habitual mouth breather. Children with any respiratory condition that makes breathing difficult through the nose. Children with any history of systemic illness and patients who require special physical and mental requirements. Children with known hypersensitivity to benzodiazepines and or indole amines. Frankel behaviour rating 1&4. Children who have recently used medication such as erythromycin or anticonvulsants. No painful past dental experience.

Design outcomes

Primary

Measure	Time frame
To compare between Intranasal Midazolam sedation and Oral Melatonin sedation in the management of anxious paediatric patients undergoing the procedure of dental extraction.Timepoint: 1-1.5 hours	—

Secondary

Measure	Time frame
To compare the effects of intranasal midazolam sedation and oral melatonin sedation on the dental anxiety on paediatric patients between the age group of 8-12 years by: 1. Measuring the level of anxiety using Modified Dental Anxiety Scale. 2. Measuring the physiological parameters i.e Pulse rate and Partial Pressure of Oxygen using a pulse oximeter. 3. Measuring the physiological parameters i.e Respiratory rate, Blood Pressure. 4. Measuring the level of sedationusing Ramsay sedation scaleTimepoint: 1-1.5 hours	—

Measure

Time frame

To compare the effects of intranasal midazolam sedation and oral melatonin sedation on the dental anxiety on paediatric patients between the age group of 8-12 years by: 1. Measuring the level of anxiety using Modified Dental Anxiety Scale. 2. Measuring the physiological parameters i.e Pulse rate and Partial Pressure of Oxygen using a pulse oximeter. 3. Measuring the physiological parameters i.e Respiratory rate, Blood Pressure. 4. Measuring the level of sedationusing Ramsay sedation scaleTimepoint: 1-1.5 hours

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Countries

India

Contacts

Public ContactDebadyuti Ghosh

Buddha Institute of Dental Sciences and Hospital

chitritagm@gmail.com

Outcome results

None listed

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