N/A
N=91
Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics
Methemoglobinemia
Bottom Line
View on ClinicalTrials.gov: NCT01402869 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Peak Methemoglobin Blood Levels — 3.55; 1.63; 1.60 percentage of methemoglobin in blood — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 4% prilocaine plain (Drug); 2% Lidocaine with 1:100,000 epinephrine (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Methemoglobin Blood Levels |
3.55; 1.63; 1.60 | <.001 sig |
| SECONDARY Time to Peak Methemoglobin Blood Levels |
62.73; 57.50; 29.50 | <.001 sig |
| SECONDARY Delta Methemoglobin Blood Level |
2.73; 0.78; 0.76 | <.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Patient scheduled to undergo comprehensive dental treatment under general anesthesia at the Koppel Special Care Dentistry Center at Loma Linda University School of Dentistry
- ASA I or II health status
- Age greater than 3 years but less than 6 years
- Weigh between 10kg and 25kg
Exclusion Criteria
- Patient not requiring restorative dental treatment
- Have a BMI less than the 5th percentile or greater than the 95th percentile for their age and gender
Data sourced from ClinicalTrials.gov (NCT01402869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.