CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91 enrolled
Drug / intervention
4% prilocaine plain +1 moredrug
Likely dose
4% prilocaine plain 5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01402869
NCT01402869N/ACompleted

Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Prilocaine Versus Lidocaine

Loma Linda University·interventional·Posted Jul 26, 2011·Updated Apr 25, 2014

In Brief

A clinical study evaluating 4% prilocaine plain and 2% Lidocaine with 1:100,000 epinephrine for Methemoglobinemia. Completed, enrolled 91 participants across 1 site.

Detailed Summary

To establish and compare maximum methemoglobin blood levels and times to maximum methemoglobin blood levels following the administration of the injectable local anesthetics prilocaine and lidocaine when used for dental treatment in pediatric patients under general anesthesia. Patients will be randomized into three equal study groups. Two of the study groups will receive local anesthetic and the third group will not. Methemoglobin blood levels will be non-invasively monitored and recorded throughout dental treatment for all groups using a Masimo Radical-7 Pulse Co-Oximeter device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2011
Enrollment StartAug 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.9 years ago

Interventions

4% prilocaine plaindrug

5mg/kg via infiltration into multiple sites of the buccal mucosa of mouth 1 time prior to start of restorative dental treatment

2% Lidocaine with 1:100,000 epinephrinedrug

2.5mg/kg via infiltration into multiple sites of buccal mucosa of mouth 1 time prior to restorative dental treatment