Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics
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ClinicalTrials.gov Identifier: NCT01402869 |
Recruitment Status :
Completed
First Posted : July 26, 2011
Results First Posted : April 25, 2014
Last Update Posted : April 25, 2014
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Sponsor:
Loma Linda University
Information provided by (Responsible Party):
Lauren GutenBerg, Loma Linda University
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label) |
Condition |
Methemoglobinemia |
Interventions |
Drug: 4% prilocaine plain Drug: 2% Lidocaine with 1:100,000 epinephrine |
Enrollment | 91 |
Participant Flow
Recruitment Details | 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. |
Pre-assignment Details | 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. |
Arm/Group Title | Prilocaine | Lidocaine | No Local Anesthetic |
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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 | 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 was administered prior to restorative dental treatment-Negative control |
Period Title: Overall Study | |||
Started | 30 | 30 | 31 |
Completed | 30 | 30 | 30 |
Not Completed | 0 | 0 | 1 |
Reason Not Completed | |||
Required Tooth Extraction | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Prilocaine | Lidocaine | No Local Anesthetic | Total | |
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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 | 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 was administered prior to restorative dental treatment-Negative control | Total of all reporting groups | |
Overall Number of Baseline Participants | 30 | 30 | 30 | 90 | |
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1 subject was withdrawn from the no local anesthetic group as the subject required 1 or more dental tooth extractions and required local anesthetic
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Months |
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Number Analyzed | 30 participants | 30 participants | 30 participants | 90 participants | |
50.97 (9.84) | 50.77 (10.19) | 50.63 (8.43) | 50.79 (9.41) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 30 participants | 30 participants | 90 participants | |
Female |
19 63.3%
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12 40.0%
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14 46.7%
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45 50.0%
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Male |
11 36.7%
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18 60.0%
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16 53.3%
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45 50.0%
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Weight Continuous
Mean (Standard Deviation) Unit of measure: Kilograms |
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Number Analyzed | 30 participants | 30 participants | 30 participants | 90 participants | |
17.17 (2.94) | 17.24 (2.78) | 17.19 (2.96) | 17.20 (2.86) | ||
ASA Health Classification
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 30 participants | 30 participants | 30 participants | 90 participants |
I-Healthy patients; no systemic disease | 26 | 25 | 24 | 75 | |
II-Patients with mild, systemic disease | 4 | 5 | 6 | 15 | |
Body Mass Index Numerical Value
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 30 participants | 30 participants | 30 participants | 90 participants | |
15.62 (1.12) | 15.69 (1.08) | 15.60 (1.03) | 15.64 (1.07) | ||
Body Mass Index Percentile
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 30 participants | 30 participants | 30 participants | 90 participants |
>=5th and <=35th percentiles | 11 | 6 | 6 | 23 | |
>35th and <=65th percentiles | 6 | 14 | 12 | 32 | |
>65th and <=95th percentiles | 13 | 10 | 12 | 35 | |
Baseline Methemoglobin Blood Level
[1] Mean (Standard Deviation) Unit of measure: Percentage |
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Number Analyzed | 30 participants | 30 participants | 30 participants | 90 participants | |
0.82 (0.39) | 0.85 (0.35) | 0.84 (0.43) | 0.83 (0.39) | ||
[1]
Measure Description: Methemoglobin blood level recorded non-invasively by the Masimo Radical-7 Pulse Co-Oximeter prior to the administration of local anesthetic or start of restorative dental procedures.
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Outcome Measures
Adverse Events
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.
More Information
Results Point of Contact
Name/Title: | Dr. Lauren Gutenberg |
Organization: | Loma Linda University |
Phone: | 909-558-4690 |
EMail: | lgutenberg@llu.edu |
Publications:
American Academy of Pediatric Dentistry. American Academy of Pediatric Dentistry 2010-2011 Definitions, Oral Health Policies, and Clinical Guidelines: Guidelines on use of local anesthetic for pediatric dental patients. Pediatr Dent 2010;32(6):156-61
Yagiela, J. Injectable and topical local anesthetics. In: ADA/PDR guide to dental therapeutics. 5th Edition. Chicago: American Dental Association Publishing Co; 2009 p. 11-2
Ash-Bernal R, Brophy GM, Kily D. Acquired methemoglobinemia in the clinical setting: an important health issue revealed. CME Zone Special Report 2006 Nov.
Dentsply Pharmaceutical. 4% Citanest Plain Package Insert. York, PA.
Responsible Party: | Lauren GutenBerg, Loma Linda University |
ClinicalTrials.gov Identifier: | NCT01402869 |
Other Study ID Numbers: |
5110172 |
First Submitted: | July 25, 2011 |
First Posted: | July 26, 2011 |
Results First Submitted: | October 15, 2013 |
Results First Posted: | April 25, 2014 |
Last Update Posted: | April 25, 2014 |