To compare two methods of using laughing gas for relaxation in children during dental treatment

Comparative Evaluation of Two Different Induction Techniques of Nitrous Oxide Sedation – A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066652

Enrollment

Registered

2024-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

None listed

Interventions

Intervention1: Nitrous oxide sedation (rapid titration): Rapid titration induction technique using nitrous oxide oxygen sedation in the ratio 50:50 to be given for 30 minutes and study period is 12 mo

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate the pre & post-op physiological parameters when using the rapid titration induction technique To evaluate the pre & post-op salivary cortisol levels when using the rapid titration induction technique To evaluate the pre & post-op psychomotor parameters when using the rapid titration induction technique To evaluate the pre & post-op analgesic effects when using the rapid titration induction technique To evaluate the pre & post-op physiological parameters when using the slow titration induction technique To evaluate the pre & post-op salivary cortisol levels when using the slow titration induction technique To evaluate the pre & post-op psychomotor parameters when using the slow titration induction technique To evaluate the pre & post-op analgesic effects when using the slow titration induction technique Timepoint: baseline & post sedation	—

Measure

Time frame

To evaluate the pre & post-op physiological parameters when using the rapid titration induction technique To evaluate the pre & post-op salivary cortisol levels when using the rapid titration induction technique To evaluate the pre & post-op psychomotor parameters when using the rapid titration induction technique To evaluate the pre & post-op analgesic effects when using the rapid titration induction technique To evaluate the pre & post-op physiological parameters when using the slow titration induction technique To evaluate the pre & post-op salivary cortisol levels when using the slow titration induction technique To evaluate the pre & post-op psychomotor parameters when using the slow titration induction technique To evaluate the pre & post-op analgesic effects when using the slow titration induction technique Timepoint: baseline & post sedation

—

Countries

India

Contacts

Public ContactDR TANU NANGIA

Manav Rachna Dental College

tanunangia.sds@mrei.ac.in9999384333

Outcome results