dental anxiety and management. Mental and behavioural disorders
Conditions
Interventions
Intervention 1: "Intervention group: Oral Melatonin tablet of 3 mg was grounded and added to 1cc of sweetened drinking water before being administered an hour prior to the actual IV sedation episode."
Treatment - Drugs
"Intervention group: Oral Melatonin tablet of 3 mg was grounded and added to 1cc of sweetened drinking water before being administered an hour prior to the actual IV sedation episode."
"Control group: Oral Midazolam Vial of 5mg was added to 1cc sweetened drinking water before being administered half an hour prior to the actual IV sedation episode."
Sponsors
Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Uncooperative chidren aged 2-6 years, completely negative Frankel behavioral scale approved by two pediatric dentists, ASA I for systemic health with at least two teeth requiring treatments like pulpotomy, restoration, stainless steel crown or extraction for two separate dental visits. Exclusion criteria: Any systemic disease with contraindications for sedation or premedication, cold symptoms, nasal obstruction, respiratory infection, limited neck movement, macroglossia, tonsillar hypertrophy, micrognathia, mouth opening limitation, not being able to remain NPO and having less than two teeth requiring the same treatment.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation. Timepoint: At the IV Administration step. Method of measurement: Houpt scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of recovery process and medication side effects. Timepoint: After the treatment ends and IV sedation reversed. Method of measurement: Observation and asking parents. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAfshin Zarghi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed