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Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics

NCT01402869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2014-04-25

Study results available
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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.

Conditions

  • Methemoglobinemia

Interventions

DRUG

4% prilocaine plain

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

DRUG

2% Lidocaine with 1:100,000 epinephrine

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

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Lauren L Gutenberg, DDS · Loma Linda University Department of Pediatric Dentistry

  • Jung-Wei Chen, DDS, MS, PhD · Loma Linda University Department of Pediatric Dentistry

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01402869 on ClinicalTrials.gov