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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
69
Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation
Cukurova University
Adana, Turkey (Türkiye)
Dental anxiety (subjective)
Units on a Scale (Patient's dental anxiety level was evaluated with Facial Image Scale after treatment. Patients signed from 1 to 5 score for dental anxiety.The data were collected and statistically analysed using by the numerical data. In this study, "1" and "2" scores are considered as better outcome. Patients who signed these scores described as no anxiety. The worst outcome is considered as the patients signed "4-5". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
Time frame: through study completion, an average of 12 months
Dental anxiety (objective)
Units on Saliva cortisol levels (Dental anxiety was evaluated with Enzyme-linked immunosorbent assay after treatment.The patients were measured from 0 to 200 nmol/L for dental anxiety after the treatment.The data were collected and statistically analysed using by the numerical data. In this study, " 0-28 nmol/L'' are considered as better outcome. Patients who were have these scores described no dental anxiety for deep sedation. The worst outcome is considered as the anxious patients have "\>28 nmol/L ". Each value range for each time interval evaluated as count of patient and presented as percentage.)
Time frame: through study completion, an average of 12 months
Depth of sedation
Units on a Scale (Depth of sedation was evaluated with Ramsay Sedation Scale during the sedation. Observer signed from 0 to 5 score for depth of sedation during the treatment.The data were collected and statistically analysed using by the numerical data. In this study, "4-5" scores are considered as better outcome. Patients who were signed these scores described as sedated patients for dental treatment. The worst outcome is considered as the patients signed "0-3". Each scale range for each time interval evaluated as count of patient and presented as percentage.)
Time frame: through study completion, an average of 12 months
Postperative complications
Units on a Scale ( Postoperative complications were evaluated with a form which was included absence or presence of agitation, hypersalivation, nausea-vomiting and double vision. Observer signed absence or presence for each complications after the treatment.The data were collected and statistically analysed using by the numerical data)
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Time frame: through study completion, an average of 12 months
Perioperative complications
Units on a Scale (Perioperative complications were evaluated with a form which was included absence or presence of local injection pain, cough, saturation drop and spontaneous movement. Observer signed absence or presence for each perioperative complications during the deep sedation.The data were collected and statistically analysed using by the numerical data)
Time frame: through study completion, an average of 12 months
Heart Rate
Differents Units of measure (Heart rate beats in bpm was measured per five minutes during the operation)
Time frame: through study completion, an average of 12 months
Systolic and diastolic arterial pressure
Differents Units of measure (Systolic and diastolic arterial pressures in mmHg were measured per five minutes during the operation)
Time frame: through study completion, an average of 12 months
Oxygen saturation
Differents Units of measure (Oxygen saturation in mmHg was measured per five minutes during the operation)
Time frame: through study completion, an average of 12 months