Trial Outcomes & Findings for Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics (NCT NCT01402869)
NCT ID: NCT01402869
Last Updated: 2014-04-25
Results Overview
The maximum percentage of methemoglobin in blood
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
Measured at 10 second intervals during dental treatment for an average of 2 hours
Results posted on
2014-04-25
Participant Flow
Patients that were greater than 3 years but less than 6 years of age that were scheduled to undergo comprehensive dental rehabilitation under general anesthesia at the Koppel Special Care Dentistry Center at Loma Linda University School of Dentistry were recruited for the study.
Enrolled participants were excluded prior to group assignment if they had a body mass index (BMI) less than the 5th percentile or greater than the 95th percentile for their age and gender.
Participant milestones
| Measure |
Prilocaine
5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
Lidocaine
2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
No Local Anesthetic
No local anesthetic was administered prior to restorative dental treatment-Negative control
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Prilocaine
5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
Lidocaine
2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
No Local Anesthetic
No local anesthetic was administered prior to restorative dental treatment-Negative control
|
|---|---|---|---|
|
Overall Study
Required Tooth Extraction
|
0
|
0
|
1
|
Baseline Characteristics
Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics
Baseline characteristics by cohort
| Measure |
Prilocaine
n=30 Participants
5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
Lidocaine
n=30 Participants
2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
No Local Anesthetic
n=30 Participants
No local anesthetic was administered prior to restorative dental treatment-Negative control
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.97 months
STANDARD_DEVIATION 9.84 • n=99 Participants
|
50.77 months
STANDARD_DEVIATION 10.19 • n=107 Participants
|
50.63 months
STANDARD_DEVIATION 8.43 • n=206 Participants
|
50.79 months
STANDARD_DEVIATION 9.41 • n=7 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Weight Continuous
|
17.17 kilograms
STANDARD_DEVIATION 2.94 • n=99 Participants
|
17.24 kilograms
STANDARD_DEVIATION 2.78 • n=107 Participants
|
17.19 kilograms
STANDARD_DEVIATION 2.96 • n=206 Participants
|
17.20 kilograms
STANDARD_DEVIATION 2.86 • n=7 Participants
|
|
ASA Health Classification
I-Healthy patients; no systemic disease
|
26 participants
n=99 Participants
|
25 participants
n=107 Participants
|
24 participants
n=206 Participants
|
75 participants
n=7 Participants
|
|
ASA Health Classification
II-Patients with mild, systemic disease
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
15 participants
n=7 Participants
|
|
Body Mass Index Numerical Value
|
15.62 kg/m^2
STANDARD_DEVIATION 1.12 • n=99 Participants
|
15.69 kg/m^2
STANDARD_DEVIATION 1.08 • n=107 Participants
|
15.60 kg/m^2
STANDARD_DEVIATION 1.03 • n=206 Participants
|
15.64 kg/m^2
STANDARD_DEVIATION 1.07 • n=7 Participants
|
|
Body Mass Index Percentile
>=5th and <=35th percentiles
|
11 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Body Mass Index Percentile
>35th and <=65th percentiles
|
6 participants
n=99 Participants
|
14 participants
n=107 Participants
|
12 participants
n=206 Participants
|
32 participants
n=7 Participants
|
|
Body Mass Index Percentile
>65th and <=95th percentiles
|
13 participants
n=99 Participants
|
10 participants
n=107 Participants
|
12 participants
n=206 Participants
|
35 participants
n=7 Participants
|
|
Baseline Methemoglobin Blood Level
|
0.82 percentage
STANDARD_DEVIATION 0.39 • n=99 Participants
|
0.85 percentage
STANDARD_DEVIATION 0.35 • n=107 Participants
|
0.84 percentage
STANDARD_DEVIATION 0.43 • n=206 Participants
|
0.83 percentage
STANDARD_DEVIATION 0.39 • n=7 Participants
|
PRIMARY outcome
Timeframe: Measured at 10 second intervals during dental treatment for an average of 2 hoursPopulation: Per protocol
The maximum percentage of methemoglobin in blood
Outcome measures
| Measure |
Prilocaine
n=30 Participants
5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
Lidocaine
n=30 Participants
2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
No Local Anesthetic
n=30 Participants
No local anesthetic was administered prior to restorative dental treatment-Negative control
|
|---|---|---|---|
|
Peak Methemoglobin Blood Levels
|
3.55 percentage of methemoglobin in blood
Standard Deviation 1.22
|
1.63 percentage of methemoglobin in blood
Standard Deviation 0.52
|
1.60 percentage of methemoglobin in blood
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Measured at 10 second intervals during dental treatment for an average of 2 hoursPopulation: per protocol
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.
Outcome measures
| Measure |
Prilocaine
n=30 Participants
5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
Lidocaine
n=30 Participants
2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
No Local Anesthetic
n=30 Participants
No local anesthetic was administered prior to restorative dental treatment-Negative control
|
|---|---|---|---|
|
Time to Peak Methemoglobin Blood Levels
|
62.73 minutes
Standard Deviation 23.78
|
57.50 minutes
Standard Deviation 30.67
|
29.50 minutes
Standard Deviation 20.36
|
SECONDARY outcome
Timeframe: 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 hoursPopulation: Per protocol
Change in percentage of methemoglobin in blood from baseline level to peak level
Outcome measures
| Measure |
Prilocaine
n=30 Participants
5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
Lidocaine
n=30 Participants
2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
|
No Local Anesthetic
n=30 Participants
No local anesthetic was administered prior to restorative dental treatment-Negative control
|
|---|---|---|---|
|
Delta Methemoglobin Blood Level
|
2.73 percentage of methemoglobin in blood
Standard Deviation 1.23
|
0.78 percentage of methemoglobin in blood
Standard Deviation 0.44
|
0.76 percentage of methemoglobin in blood
Standard Deviation 0.48
|
Adverse Events
Prilocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Local Anesthetic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place