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Completed

NCT Number: NCT04623970

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

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.

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Key information

Conditions

Anxiety Postoperative

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental treatment

Procedure

Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation

Primary outcomes

  1. Dental anxiety (subjective)

    Time frame: through study completion, an average of 12 months

    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.)

  2. Dental anxiety (objective)

    Time frame: through study completion, an average of 12 months

    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.)

  3. Depth of sedation

    Time frame: through study completion, an average of 12 months

    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.)

  4. Postperative complications

    Time frame: through study completion, an average of 12 months

    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)

  5. Perioperative complications

    Time frame: through study completion, an average of 12 months

    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 outcomes

  1. Heart Rate

    Time frame: through study completion, an average of 12 months

    Differents Units of measure (Heart rate beats in bpm was measured per five minutes during the operation)

  2. Systolic and diastolic arterial pressure

    Time frame: through study completion, an average of 12 months

    Differents Units of measure (Systolic and diastolic arterial pressures in mmHg were measured per five minutes during the operation)

  3. Oxygen saturation

    Time frame: through study completion, an average of 12 months

    Differents Units of measure (Oxygen saturation in mmHg was measured per five minutes during the operation)

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Çocuk Hastalarda Değişik Konsantrasyonlarda Kullanılan Sedasyon Ajanlarının Anksiyete Üzerine Etkilerinin Değerlendirilmesi

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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