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EFFECT OF FLAVOURING AGENTS ON ACCEPTANCE OF ORAL MIDAZOLAM IN CHILDREN

Comparitative evaluation of palatibility enhanching agents to improve acceptance of oral midazolam in pediatric dentistry -a cross sectional study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/109961
Enrollment
60
Registered
2026-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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: oral midazolam will be administered at a dose of 0.75 mg/kg (strength of midazolam: 5 mg/mL) after being mixed with 0.5 mL/kg of the selected palatability-enhancing agent (pa

Sponsors

DRDRISHADVATI MUKHERJEE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients classified as ASA Physical Status I or II will be included Documentation of negative behaviour will be recored, defined as scores I and II on Frankl s Behaviour Rating Scale Informed consent will be obtained from the parents or legal guardians, along with assent from the child where applicable

Exclusion criteria

Exclusion criteria: Children with a known history of allergy to benzodiazepines will be excluded Children with an altered mental status will be excluded Children with gastrointestinal disorders that could affect the absorption of midazolam will be excluded Children with anaemia (haemoglobin levels less than 10 g/dL) will be excluded Children with obesity, snoring, stridor, sleep apnea, maxillofacial malformations, a history of previous airway difficulty, gastrointestinal reflux, or acute reactive airway disease will be excluded Children with an eventful past sedation history will be excluded Dental procedures with a duration exceeding 30 minutes will be excluded from the study

Design outcomes

Primary

MeasureTime frame
The study aims to comparatively evaluate the effectiveness of various palatability-enhancing agents in improving the taste acceptability and overall patient compliance of oral midazolam in paediatric dental patients, as determined by the child s preference.Timepoint: 6 months

Secondary

MeasureTime frame
not applicableTimepoint: not applicable

Countries

India

Contacts

Public ContactDRDRISHADVATI MUKHERJEE

AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES

hod.pedo.absmids@nitte.edu.in9845451954

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026