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OpenTrials
Completed

NCT Number: NCT06218173

Local Anesthesia Impact on Dental Sedation

The goal of this observational study is to investigate the impact of local anesthesia in health children who were sedated for dental procedures.

The main questions it aims to answer are:

* Impact of local anesthesia on sedation depth and hemodynamic parameters * Impact of presence of local anesthesia on the requirement of propofol to maintain deep sedation.

Participants were deeply sedated and one group received local anesthesia at the anesthesia induction, while other group of patients received local anesthesia after the maintenance anesthesia was discontinued.

If there is a comparison group:

Completed

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Key information

Conditions

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Dentistry

Ankara, 06560, Turkey (Türkiye)

About this study

Local anaesthesia (LA) is often preferred for stabilization of vital signs, depth of anaesthesia in dental restorations but the optimal timing of LA administration during sedation is varies according to personal preferences of dentists. Aim of this retrospective study is to investigate the effects of the timing of LA on hemodynamic parameters, depth of anaesthesia and total dose of anaesthetic drugs given in paediatric patients sedated for dental procedures.

Records of healthy children who were sedated for dental restorations will be divided into two groups. Patients who received LA at the beginning of sedation or who received LA at the end of sedation after completion of restorations. It is planned to compare the patient groups in terms of demographic data, hemodynamic data, BIS scores, Ramsey Sedation Scale scores, total propofol dose administered.

Who can participate

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

Inclusion criteria

Paediatric dental patients who were previously sedated and fulfilled the following inclusion criteria were included in this investigation. Patients with an American Society of Anesthesiologist (ASA) physical status classification of I-II and aged between 2 and 8 years were included in the study.

Exclusion criteria

Exclusion criteria

were ASA status III-V, age older than 8 years, having any history of allergy to anaesthetic drugs and renal disease interfering with drug metabolism.

Treatment and study plan

Primary outcomes

  1. Estimate the effect of local anesthesia on sedation depth

    Time frame: 1 year

  2. Estimate the effect of local anesthesia on hemodynamic parameters

    Time frame: 1 year

  3. Estimate the effect of local anesthesia on total propofol requirement

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Clinical Impact of Local Anaesthetic Timing on Sedation Stability and Propofol Dosage in Paediatric Dental Sedation

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

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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