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A Study Comparing Three Nasal Sedative Medicines (Dexmedetomidine, Midazolam, and Ketamine) in Children Receiving Dental Treatment

Evaluation and comparison of the sedative efficiency of intranasal Dexmedetomidine, Midazolam, Ketamine and their effect on behavior in pediatric dental patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260702007
Enrollment
27
Registered
2026-07-02
Start date
2025-12-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

efficiency of intranasal sedative drugs Midazolam, Dexmedetomidine and Ketamine and effect on behaviour in children below 12 years of age showing disruptive behaviour on dental chair Intranasal route Sedation Dexmedetomidine Midazolam Ketamine

Interventions

The solution of the drug was titred and loaded into a 5cc luer Lock Syringe and administered into the nostrils using the mucosal atomisation device by the anesthetist who also monitored the patient c
Active Comparator Drug,Active Comparator Drug,Active Comparator Drug
Intranasal Dexmedetomidine ,Intranasal Ketamine,Intranasal Midazolam

Sponsors

HAMNA HUSSAIN
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children upto 12 years of age. 2. Children requiring dental treatment and who cannot be managed through basic behavior management techniques. 3. Children falling under American Society of Anesthesiologist Physical Status Classification I and II (ASAI and ASAII).

Exclusion criteria

Exclusion criteria: 1. children who can be managed with basic behaviour management techniques on dental chair 2 ASA III and IV 3. children requiring extensive dental treatment

Design outcomes

Primary

MeasureTime frame
depth of sedation during the dental treatment Ramsay Sedation Score was used to assess the depth of sedation on a six-point scale ranging from anxious and agitated (Score 1) to unresponsive (Score 6),duration of action onset and discharge minutes,onset of sedation sedation signs minutes,ease of treatment completion end of treatment Ease of Treatment Completion Scale is used in sedation to assess the child's cooperation and the operator's ability to complete the planned dental procedure under sedation,higher scores better ease,vital parameters every 10 minutes intervals B.P , HEART RATE, RESPIRATORY RATE, SpO2

Secondary

MeasureTime frame
effect on behaviour pre treatment during and post treatment Frankl Behaviour Rating Scale was used to evaluate child behavior on a four-point scale ranging from definitely negative (- - ) to definitely positive (+ +).

Countries

India

Contacts

Public ContactHAMNA HUSSAIN

Pushpagiri College of Dental Sciences

hamnahussain997@gmail.com07012195415

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026