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NCT04500158

The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort

Completed Phase 3 Results posted Last updated 19 September 2024
What this trial tests

Phase 3 trial testing Lidocaine in Pain, Procedural in 59 participants. Completed in 28 February 2024.

Timeline
3 November 2020
Primary endpoint
28 February 2024
28 February 2024

Quick facts

Lead sponsorVirginia Commonwealth University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposesupportive care
Enrollment59
Start date3 November 2020
Primary completion28 February 2024
Estimated completion28 February 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Virginia Commonwealth University

Who can join

Under 6, any sex, with Pain, Procedural. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post Operative Pain Primary · in the evening of the day of surgery, up to 10 hours

The Parent's Postoperative Pain Measure ( abbreviated: PPPM) Scale consists of 15 questions with scores ranging from 0 to 15, with one point assigned to each question answered with a "Yes" and therefore higher scores indicating worse postoperative pain. A score of 6 or greater is considered clinically significant pain which was tallied for the primary outcome measure (i..e number of participants experiencing clinically significant postoperative pain).

GroupValue95% CI
Local Anesthesia13
Standard Care10
Number of Teeth Treated Secondary · start of procedure to end of procedure, the intraoperative time frme

Will report the mean and standard deviation of number of teeth treated

GroupValue95% CI
Local Anesthesia8.6± 3.4
Standard Care7.4± 3.4
Procedure Time Secondary · start of procedure to end of procedure, minutes

Will report the mean and standard deviation of the procedure time

GroupValue95% CI
Local Anesthesia85.4± 32.8
Standard Care70.6± 29
PACU Time Secondary · time from after procedure to through time in the post-anesthesia care unit in minutes

Will report the mean and standard deviation of time after the procedure to through time in the post-anesthesia care unit

GroupValue95% CI
Local Anesthesia39.8± 11.6
Standard Care39.9± 9.3

Sponsor's own description

The purpose of this study is to compare patient responses during and after surgery when local anesthetic is used for dental treatment under general anesthesia (GA) and when it is not used.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lidocaine

Trials testing the same drug.

Other recruiting trials for Pain, Procedural

Currently open trials in the same condition.

Other Virginia Commonwealth University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04500158.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing