NCT06218173

Brief 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:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 12, 2024

Last Update Submit

January 12, 2024

Conditions

Sedative Overdose

Outcome Measures

Primary Outcomes (3)

  • Estimate the effect of local anesthesia on sedation depth

    1 year

  • Estimate the effect of local anesthesia on hemodynamic parameters

    1 year

  • Estimate the effect of local anesthesia on total propofol requirement

    1 year

Study Arms (2)

Early LA group

The group that received LA at the induction of the sedation

Late LA group

The group that received LA at the end of the sedation

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

ASA I-II pediatric patients who were deeply sedated for dental restorations in a tertiary university hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, 06560, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 23, 2024

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 30, 2022

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

TU(1)