Behavior Management
Conditions
Brief summary
The aim of this study is to evaluate the effect of audio analgesia (using binaural beats and instrumental music) in conjunction with a minimal dose of intranasal aerosolized midazolam on acquiring satisfactory patient cooperation.
Interventions
OTHERAudio analgesia
Patients received a procedural sedation session using audio analgesia using binaural beats and instrumental music
DRUG0.3 mg/kg midazolam
Patients received a procedural sedation session, using aerosolized solution of 0.3 mg/kg Midazolam
DRUG0.5 mg/kg midazolam
Patients received a procedural sedation session, using aerosolized solution of 0.5 mg/kg Midazolam
Sponsors
Rania Ahmedien
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* Frankl scale score 1 or 2 (Definitely Negative or Negative behavior) * American Society of Anesthesiologist I, II physical status (ASA I, II) * Patient presenting with at least one primary molar indicated for extraction. * Parent/guardian written consent.
Exclusion criteria
* Medically compromised patients. * Cognitively impaired patients. * Hearing disabilities. * Mouth breathers. * Hypersensitivity to local anesthetic drugs used. * Patients with known allergy to midazolam. * Teeth with ankylosed roots
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of treatment completion | throughout the procedure completion | The ease of treatment completion was measured using a five point scale (1-5) with higher scores indicating easier treatment |
| Child's dental anxiety | throughout the procedure completion | It was assessed using Venham's Clinical Anxiety Scale with scores ranging 0 (best) to 5 (worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic effect | throughout the procedure completion | It was assessed using the FLACC scale. The scale is scored in a range of 0-10 with 0 representing no pain. |
| Sedation Depth | throughout the procedure completion | The sedation depth was assessed by the Richmond Agitation Sedation Scale with scores ranging from -5 to +4, with lower scores indicating deeper sedation |
| Parental satisfaction | throughout the procedure completion | The parents/guardians will be asked to rate their overall satisfaction with care under sedation by using a simple image of 5 point Likert scale with higher scores indicating greater satisfaction |
| Oxygen saturation | From enrollment and throughout procedure completion | — |
| Heart rate | From enrollment and throughout procedure completion | — |
| Blood pressure | From enrollment and throughout procedure completion | — |
Countries
Egypt
Outcome results
None listed