Local Anesthesia Impact on Dental Sedation

Sedative Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06218173
• Other study ID #: 36290600/55
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2024
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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:

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Overdose
• Sedative Overdose

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the effect of local anesthesia on sedation depth		1 year
Primary	Estimate the effect of local anesthesia on hemodynamic parameters		1 year
Primary	Estimate the effect of local anesthesia on total propofol requirement		1 year