Trial · NCT01402869
Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics
NCT01402869, Not applicable, Completed, Loma Linda University; results first posted 2014-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics. Trials, record NCT01402869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01402869
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics
- NCT number
- NCT01402869
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 91 participants, actual
- Lead sponsor
- Loma Linda University
- Conditions
- Methemoglobinemia
- Interventions
- 4% prilocaine plain, 2% Lidocaine with 1:100,000 epinephrine
- First posted
- 2011-07-26
- Last updated
- 2014-04-25
- Results first posted
- 2014-04-25
- Limitations and caveats
Did not compare locals anesthetics with equivalent concentrations of epinephrine; unable to control length of time methemoglobin blood levels were monitored as all subjects varied in extent of restorative dental procedures needed.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Methemoglobin Blood Levels | Measured at 10 second intervals during dental treatment for an average of 2 hours | The maximum percentage of methemoglobin in blood |
| Secondary | Time to Peak Methemoglobin Blood Levels | Measured at 10 second intervals during dental treatment for an average of 2 hours | The length of time between the administration of local anesthetic (Prilocaine and Lidocaine Groups) or start of restorative dental procedures (No local anesthetic Group) and the time at which the maximum methemoglobin blood level is observed. |
| Secondary | Delta Methemoglobin Blood Level | From administration of local anesthetic or start of restorative procedures to time at which maximum methemoglobin blood level was documented during dental treatment for an average of 2 hours | Change in percentage of methemoglobin in blood from baseline level to peak level |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Peak Methemoglobin Blood Levels | Measured at 10 second intervals during dental treatment for an average of 2 hours | Per protocol | percentage of methemoglobin in blood | MEAN |
| SECONDARY | Time to Peak Methemoglobin Blood Levels | Measured at 10 second intervals during dental treatment for an average of 2 hours | per protocol | minutes | MEAN |
| SECONDARY | Delta Methemoglobin Blood Level | From administration of local anesthetic or start of restorative procedures to time at which maximum methemoglobin blood level was documented during dental treatment for an average of 2 hours | Per protocol | percentage of methemoglobin in blood | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Peak Methemoglobin Blood Levels | Prilocaine | 3.55 | Standard Deviation 1.22 | percentage of methemoglobin in blood | |
| Peak Methemoglobin Blood Levels | Lidocaine | 1.63 | Standard Deviation 0.52 | percentage of methemoglobin in blood | |
| Peak Methemoglobin Blood Levels | No Local Anesthetic | 1.60 | Standard Deviation 0.45 | percentage of methemoglobin in blood | |
| Time to Peak Methemoglobin Blood Levels | Prilocaine | 62.73 | Standard Deviation 23.78 | minutes | |
| Time to Peak Methemoglobin Blood Levels | Lidocaine | 57.50 | Standard Deviation 30.67 | minutes | |
| Time to Peak Methemoglobin Blood Levels | No Local Anesthetic | 29.50 | Standard Deviation 20.36 | minutes | |
| Delta Methemoglobin Blood Level | Prilocaine | 2.73 | Standard Deviation 1.23 | percentage of methemoglobin in blood | |
| Delta Methemoglobin Blood Level | Lidocaine | 0.78 | Standard Deviation 0.44 | percentage of methemoglobin in blood | |
| Delta Methemoglobin Blood Level | No Local Anesthetic | 0.76 | Standard Deviation 0.48 | percentage of methemoglobin in blood |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prilocaine | 30 | |
| Overall Study | STARTED | Lidocaine | 30 | |
| Overall Study | STARTED | No Local Anesthetic | 31 | |
| Overall Study | COMPLETED | Prilocaine | 30 | |
| Overall Study | COMPLETED | Lidocaine | 30 | |
| Overall Study | COMPLETED | No Local Anesthetic | 30 | |
| Overall Study | NOT COMPLETED | Prilocaine | 0 | |
| Overall Study | NOT COMPLETED | Lidocaine | 0 | |
| Overall Study | NOT COMPLETED | No Local Anesthetic | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prilocaine | ||
| Total, all-cause mortality | Lidocaine | ||
| Total, all-cause mortality | No Local Anesthetic | ||
| Total, other adverse events | Prilocaine | 0 | 30 |
| Total, other adverse events | Lidocaine | 0 | 30 |
| Total, other adverse events | No Local Anesthetic | 0 | 30 |
| Total, serious adverse events | Prilocaine | 0 | 30 |
| Total, serious adverse events | Lidocaine | 0 | 30 |
| Total, serious adverse events | No Local Anesthetic | 0 | 30 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01402869
GET https://conductscience.org/api/trials/v1/NCT01402869/registered