Evaluation of the Effects Using the Combination of Sedative Agents on Dental Anxiety in Pediatric Patients

Çukurova University

Status: Completed

Conditions: Anxiety Postoperative

Treatments: Procedure: Dental Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04623970

82/2

Details and patient eligibility

About

The aims of this study were firstly, to evaluate the changes in the anxiety level after deep sedation with various intravenous sedative agents using salivary cortisol level in pediatric dental patients and secondly, to compare clinical effectiveness of this sedative agents, perioperative complications, recovery time and adverse effects.

Full description

This clinical study was included 69 healthy pediatric patients aged 3 to 7 years with high anxiety. The patients were divided into 3 groups according to the sedative agents: Group 1 (n=23) was received Propofol, Group 2 (n=23) was receieved Ketofol 1:3, and Group 3 (n=23) was received Ketofol 1:4. The anxiety levels were assessed using Facial Image Scale (FIS) anxiety scale and changes in salivary cortisol levels were assessed using ELISA before and after the drug administration. Perioperative vital signs, depth of sedation were recorded at intervals of 5 minutes. Preoperative and postoperative complications, operation and recovery time were recorded in the follow-up form.

Enrollment: 69 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pediatric patients age between 3-7 years old
• Having no systemic condition and ASA 1 healty status
• Having high dental anxiety
• Having no dental treatment under the sedation or general anesthesia before
• Having no dental treatment before

Exclusion criteria

• Having obstructed nasal passages, raised intracranial or intraocular pressure, allergy
• Using any drug which effected saliva construction
• Having enough saliva for saliva cortisol evaluation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

69 participants in 3 patient groups

Propofol sedation group

Experimental group

Description:

Patients in this experimental group received propofol sedation agent.

Treatment:

Procedure: Dental Treatment

Ketofol 1:3 sedation group

Experimental group

Description:

Patients in this experimental group received ketofol sedation agent as a 1:3 mixture.

Treatment:

Procedure: Dental Treatment

Ketofol 1:4 sedation group

Experimental group

Description:

Patients in this experimental group received ketofol sedation agent as a 1:4 mixture.

Treatment:

Procedure: Dental Treatment