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Oral midazolam or intranasal dexmedetomidine in paediatric dental treatment

A comparison of oral midazolam with intranasal dexmedetomidine in paediatric patients requiring restorative dental treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004335
Enrollment
30
Registered
2014-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration

Interventions

Intervention1: Intranasal Dexmedetomidine: intranasal Dexmedetomidine 2.5mcg/kg along with oral plain honey was administered 25-30 minutes before start of dental procedure Control Intervention1: Oral

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: uncooperative children aged 2-6years who were scheduled for restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration

Exclusion criteria

Exclusion criteria: Patients with previous exposure to dental sedation, neurodevelopmental anomalies, abnormal cardiac anatomy, Craniofacial anatomical defects , allergy to EMLA cream, allergy to study drugs

Design outcomes

Primary

MeasureTime frame
Dose of ketamine required to keep acceptable Houpts scores for procedureTimepoint: during the 20-30 minutes of proceudre

Secondary

MeasureTime frame
Ramsay sedation Scores, Heart rate, non invasive blood pressureTimepoint: Ramsay sedation score-before premedication, and 15 and 30 minutes after premedication, after procedure heart rate and non invasive blood pressure- at above mentioned times as well as during procedure

Countries

India

Contacts

Public ContactDr Babita Ghai

Post Graduate Institute of Medical Education and Research, Chandigarh

ghaibabita@hotmail.com9914209533

Outcome results

None listed

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