Skip to content

A Clinical Trial comparing pain perception of children under midazolam sedation to local anesthesia administered with 2 different syringe systems for dental treatment.

The pain reaction of children under midazolam sedation to local anesthesia administered with a disposable vs a cartridge syringe a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076409
Enrollment
30
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Pain Perception Under Sedation: Cartridge vs. Insulin Syringes: To compare pain reaction of children under midazolam sedation to buccal and palatal local anesthesia administered with ca

Sponsors

Dr Medhashree Tumuluri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 2-5years. 2. Children with no prior dental history. 3. Children requiring dental extraction. 4. Children indicated for moderate sedation with midazolam. 5. American Association of Anaesthesiologist (ASA) 1 and 2 children.

Exclusion criteria

Exclusion criteria: 1. Children contraindicated for dental treatment under midazolam. 2. Children with emergency treatment needs, such as abscess, cellulitis and space infection. 3. Children allergic to lignocaine or any component of local anaesthetic solution

Design outcomes

Primary

MeasureTime frame
To compare pain reaction of children to local anesthesia administered with cartridge vs the disposable insulin syringes using FLACC scaleTimepoint: baseline and during administration of local anesthesia (lignocaine)

Secondary

MeasureTime frame
pain reaction during buccal vs. palatally administered local anesthesiaTimepoint: During administration

Countries

India

Contacts

Public ContactDr Medhashree Tumuluri

Manipal College of Dental Sciences Mangalore

ashwin.rao@manipal.edu9945510215

Outcome results

None listed

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