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Comparison of Efficacy in Sedation of Oral Melatonin, Intranasal Midazolam, and Inhaled Nitrous Oxide in Children Aged 4 to 7 Years: A Randomized Controlled Trial.

Comparison of Efficacy in Sedation of Oral Melatonin, Intranasal Midazolam, and Inhaled Nitrous Oxide in Children Aged 4 to 7 Years: A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/087509
Enrollment
60
Registered
2025-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Intervention1: Nil: Nil

Sponsors

shweta tyagi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. INCLUSION CRITERIA: - a) Children between 4 and 7 years old. b) Need for local anesthesia for dental, minor surgical, or other procedures where the child might not cooperate without sedation. c) Children with no systemic disease d) No known allergies or contraindications to the sedative drugs planned for use.

Exclusion criteria

Exclusion criteria: 2. EXCLUSION CRITERIA: - a) Children below 4 and above 7 years old. b) Children with severe systemic diseases. c) Dental treatment not requiring injectable LA. d) Subjects exhibiting positive behaviour.

Design outcomes

Primary

MeasureTime frame
To comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration.Timepoint: In a randomized study, 60 children with age group 4 to 7 with Frankl s behavior rating scale 2 and 3, received premedication, Group A- 3 mg/kg per dose of Oral melatonin 60 minute before the procedure (n=20), Group B- 0.2 mg/kg intranasal midazolam 60 minute before the local anaesthetic administration (n=20), Group C- preadjusted mixture of nitrous oxide oxygen sedation was administered in the concentration of 30 70% using Matrx Porter Digital Relative analgesia machine (n-20).

Secondary

MeasureTime frame
comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration.Timepoint: 1. To determine the efficacy of oral melatonin to intranasal midazolam 2. Efficacy of intranasal midazolam to nitrous oxide sedation

Countries

India

Contacts

Public ContactSHWETA TYAGI

SHREE BANKEY BIHARI DENTAL COLLEGE AND HOSPITAL

tshweta964@gmail.com09654325788

Outcome results

None listed

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