Health Condition 1: Z012- Encounter for dental examination and cleaning
Conditions
Interventions
Intervention1: Arm A: 30% Nitrous oxide: Dose/Concentration: 30% Nitrous oxide with 70% Oxygen
Route of Administration: Inhalation via nasal hood
Frequency: Single administration per dental visit
Tota
Sponsors
Charanya S
Eligibility
Inclusion criteria
Inclusion criteria: Children aged seven to twelve years requiring treatment under local anaesthesia through inferior alveolar nerve block in each visit for three visits. Children with Frankel behaviour rating two. Medically healthy children classified as American Society of Anesthesiologists physical status class one. Children who can understand and follow instructions during the procedure. Children whose parent or guardian have given consent and child assent for participation in the study.
Exclusion criteria
Exclusion criteria: Children with severe anxiety or uncooperative behavior that may require deeper sedation or general anesthesia. History of respiratory conditions such as asthma, upper airway obstruction, or sleep apnea. Neurological or developmental disorders that could affect sedation response such as epilepsy, autism spectrum disorder, or attention deficit hyperactivity disorder. Allergy or hypersensitivity to nitrous oxide or local anesthetic agents. Children with significant nasal congestion or conditions affecting nasal breathing. Recent history of sedative or anxiolytic medication use within the past twenty four hours. Severe gag reflex or conditions making nitrous oxide administration difficult. Children who have undergone recent dental procedures with sedation within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pain perceived at different concentrations of nitrous oxide sedation (30% and 40%) and control (no sedation) during local anesthesia administrationTimepoint: Subjective pain scale scored during administration of local anesthesia injection using Face, Legs, Activity, Cry, Consolability scale. Objective pain scale scored Immediately after completion of local anesthesia injection using Wong Baker faces pain rating scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate & compare anxiety levels before & after local anesthesia administration under thirty percent & forty percent nitrous oxide sedation. To determine the depth of sedation achieved with thirty percent & forty percent nitrous oxide. To compare recovery time following dental procedures under different sedation concentrations.Timepoint: Anxiety level by Visual Analogue Scale for Anxiety at baseline before local anesthesia & immediately after injection. Sedation depth by Wisconsin Sedation Scale at five minutes after induction of nitrous oxide oxygen inhalation before local anesthesia. Heart rate & oxygen saturation at baseline, during injection, immediately after, & during recovery every five minutes until complete recovery. Recovery status by Modified Aldrete Score during recovery every five minutes until complete recovery. | — |
Countries
India
Contacts
Public ContactDr Shankar P
SRM Dental College, Ramapuram
Outcome results
None listed