pediatric dental clinic
Conditions
Interventions
Group 1:midazolam oral solution (specification: 10 ml, 20 mg, Yichang Renfu Pharmaceuticals, State Pharmaceutical License No. H20213321) at 0.5 mg/kg
Group 2:midazolam oral solution (specification: 10 ml, 20 mg, Yichang Renfu Pharmaceuticals, State Pharmaceutical License No. H20213321) at 0.75 mg/kg
Sponsors
Stomatological Hospital Of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. 3 years <= age <= 6 years. 2. Patients with ASA scores I to II. 3. Low risk of airway obstruction (Mallampati score I~II). 4. Born at full term. 5. Children who present with preoperative anxiety or fear (score 2-3 according to the Frankl Treatment Adherence Assessment Scale). 6. There are teeth in the mouth (dental caries, pulpitis, apical periodontitis, etc.) who need treatment 7. Willing to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Children who demonstrate active cooperation or extreme fear (score of 1 or 4 according to the Frankl Treatment Adherence Rating Scale) prior to surgery; 2. A history of cerebral palsy, autism or other psychiatric disorders, with ongoing use of psychotropic medication; 3. Recent alcohol use, other medications, especially blood pressure medications, antibiotics, opioid analgesics; 4. Known hypersensitivity to midazolam or other ingredients of this product. Children with acute angle-closure glaucoma or untreated open-angle glaucoma; 5. A combination of severe cardiac, cerebral, hepatic or renal system insufficiency caused by; 6 Respiratory tract infection or obstructive disease in the past week; 7. Unable to cooperate with the study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parental Separation Anxiety Scale, PSAS;Ramsay >= 4 time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The child's basic vital signs;Parent satisfaction rating; | — |
Countries
China
Contacts
Public ContactCong Yu
Stomatological Hospital Of Chongqing Medical University
Outcome results
None listed