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efficacy of inhalational , intranasal and oral sedatives in managing behaviour of pediatric dental patients: a randomized controlled trial

COMPARISON OF THE EFFICACY OF INHALATIONAL, INTRANASAL AND ORAL SEDATIVES IN PEDIATRIC DENTAL PATIENT MANAGEMENT: A RANDOMIZED CONTROLLED TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080613
Enrollment
120
Registered
2025-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: xk: kmx Intervention2: intranasal midazolam: midazolam is a short-acting, water-soluble benzodiazepine that provides anxiolysis, sedation and amnesia effects. It acts by activating the

Sponsors

Dr Aanchal Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Anxious children aged between 4-8 years. Children having a physical status of ASA I according to the American Society of Anaesthesiologists. Children having Frankl behaviour rating scale- positive. Children who require a dental procedure under local anaesthesia. Fasting status of children light meal 2 hours before undergoing dental procedure.

Exclusion criteria

Exclusion criteria: Very uncooperative children (frankl behaviour rating definitive negative) . Children who recently used medications like erythromycin or anticonvulsants that may interfere with the pharmacokinetics of midazolam. Children with known hypersensitivity to nitrous oxide -oxigen sedation, intranasal midazolam and triclofos. Children with any systemic disease and special health care needs. Children with any condition that predisposes them to airway obstruction or difficulties (eg COPD, allergic rhinitis, adenoid hyperplasia, nasal septum problems, enlarged turbinates or nasal polyp). Children with upper or lower respiratory tract infections.

Design outcomes

Primary

MeasureTime frame
Level of sedation of the patient will be assessed by Modified Ramsay sedation sale. pain perception will be assessed by using wong-baker faces pain rating scale. Timepoint: immediate

Secondary

MeasureTime frame
overall behaniour will be asses by using Houpt Sedation Rating Scale.Timepoint: immediate

Countries

India

Contacts

Public ContactDr Nikhil Srivastva

Subharti Dental College and Hospital

drnikhilpedo@gmail.com9639000645

Outcome results

None listed

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