Clinical trial NCT04623970: Evaluation of the Effects Using the Combination of Sedative Agents on Dental Anxiety in Pediatric Patients
Official title: Çocuk Hastalarda Değişik Konsantrasyonlarda Kullanılan Sedasyon Ajanlarının Anksiyete Üzerine Etkilerinin Değerlendirilmesi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Postoperative
Keywords: Dental anxiety
Deep Sedation
Ketofol
Propofol
Salivary Cortisol
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 69
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dental anxiety (subjective)
timeFrame: through study completion, an average of 12 months
measure: Dental anxiety (objective)
timeFrame: through study completion, an average of 12 months
measure: Depth of sedation
timeFrame: through study completion, an average of 12 months
measure: Postperative complications
timeFrame: through study completion, an average of 12 months
measure: Perioperative complications
timeFrame: through study completion, an average of 12 months
Secondary outcomes:
measure: Heart Rate
timeFrame: through study completion, an average of 12 months
measure: Systolic and diastolic arterial pressure
timeFrame: through study completion, an average of 12 months
measure: Oxygen saturation
timeFrame: through study completion, an average of 12 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Cukurova University
name: volkan Ciftci
role: STUDY_DIRECTOR
References: