To compare two methods of using laughing gas for relaxation in children during dental treatment
Phase 3
- Registration Number
- CTRI/2024/05/066652
- Lead Sponsor
- ot Applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children aged 4-8 years
Frankl’s Behavior Rating 2 (negative), 3 (positive)
ASA I category children
Primary teeth indicated for vital pulp therapy
Children with no previous experience of intraoral local anesthesia
Children whose parent / guardian gives written consent for the procedure
Exclusion Criteria
Children with upper respiratory tract infection
Children with blocked nose
Patient with extraoral and intraoral swellings
Patient with any systemic disease
Children with special healthcare needs
Children allergic to local anaesthetic agent (after test dose)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare and evaluate the differences in salivary cortisol levels, physiological psychomotor parameters and analgesic effects between the rapid and slow titration induction techniquesTimepoint: base line and post sedation
- Secondary Outcome Measures
Name Time Method To evaluate the pre & post-op physiological parameters when using the rapid titration induction technique <br/ ><br>To evaluate the pre & post-op salivary cortisol levels when using the rapid titration induction technique <br/ ><br>To evaluate the pre & post-op psychomotor parameters when using the rapid titration induction technique <br/ ><br>To evaluate the pre & post-op analgesic effects when using the rapid titration induction technique <br/ ><br>To evaluate the pre & post-op physiological parameters when using the slow titration induction technique <br/ ><br>To evaluate the pre & post-op salivary cortisol levels when using the slow titration induction technique <br/ ><br>To evaluate the pre & post-op psychomotor parameters when using the slow titration induction technique <br/ ><br>To evaluate the pre & post-op analgesic effects when using the slow titration induction technique <br/ ><br>Timepoint: baseline & post sedation