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

Primary Purpose

Anxiety Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dental Treatment
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Postoperative focused on measuring Dental anxiety, Deep Sedation, Ketofol, Propofol, Salivary Cortisol

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts 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

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Propofol sedation group

Ketofol 1:3 sedation group

Ketofol 1:4 sedation group

Arm Description

Patients in this experimental group received propofol sedation agent.

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

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

Outcomes

Primary Outcome Measures

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.)
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.)
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.)
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)
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)

Secondary Outcome Measures

Heart Rate
Differents Units of measure (Heart rate beats in bpm was measured per five minutes during the operation)
Systolic and diastolic arterial pressure
Differents Units of measure (Systolic and diastolic arterial pressures in mmHg were measured per five minutes during the operation)
Oxygen saturation
Differents Units of measure (Oxygen saturation in mmHg was measured per five minutes during the operation)

Full Information

First Posted
November 2, 2020
Last Updated
November 10, 2020
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT04623970
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Postoperative
Keywords
Dental anxiety, Deep Sedation, Ketofol, Propofol, Salivary Cortisol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol sedation group
Arm Type
Experimental
Arm Description
Patients in this experimental group received propofol sedation agent.
Arm Title
Ketofol 1:3 sedation group
Arm Type
Experimental
Arm Description
Patients in this experimental group received ketofol sedation agent as a 1:3 mixture.
Arm Title
Ketofol 1:4 sedation group
Arm Type
Experimental
Arm Description
Patients in this experimental group received ketofol sedation agent as a 1:4 mixture.
Intervention Type
Procedure
Intervention Name(s)
Dental Treatment
Intervention Description
Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation
Primary Outcome Measure Information:
Title
Dental anxiety (subjective)
Description
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
Title
Dental anxiety (objective)
Description
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
Title
Depth of sedation
Description
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
Title
Postperative complications
Description
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)
Time Frame
through study completion, an average of 12 months
Title
Perioperative complications
Description
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
Secondary Outcome Measure Information:
Title
Heart Rate
Description
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
Title
Systolic and diastolic arterial pressure
Description
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
Title
Oxygen saturation
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
35 Male and 34 Female
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
volkan Ciftci
Organizational Affiliation
Cukurova University
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
Country
Turkey

12. IPD Sharing Statement

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

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