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Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lauren GutenBerg, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01402869
First received: July 25, 2011
Last updated: March 25, 2014
Last verified: March 2014
Results First Received: October 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Methemoglobinemia
Interventions: Drug: 4% prilocaine plain
Drug: 2% Lidocaine with 1:100,000 epinephrine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Prilocaine     Lidocaine     No Local Anesthetic  
STARTED     30     30     31  
COMPLETED     30     30     30  
NOT COMPLETED     0     0     1  
Required Tooth Extraction                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
1 subject was withdrawn from the no local anesthetic group as the subject required 1 or more dental tooth extractions and required local anesthetic

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Prilocaine     Lidocaine     No Local Anesthetic     Total  
Number of Participants  
[units: participants]
  30     30     30     90  
Age  
[units: months]
Mean ± Standard Deviation
  50.97  ± 9.84     50.77  ± 10.19     50.63  ± 8.43     50.79  ± 9.41  
Gender  
[units: participants]
       
Female     19     12     14     45  
Male     11     18     16     45  
Weight Continuous  
[units: kilograms]
Mean ± Standard Deviation
  17.17  ± 2.94     17.24  ± 2.78     17.19  ± 2.96     17.20  ± 2.86  
ASA Health Classification  
[units: 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  
[units: kg/m^2]
Mean ± Standard Deviation
  15.62  ± 1.12     15.69  ± 1.08     15.60  ± 1.03     15.64  ± 1.07  
Body Mass Index Percentile  
[units: 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]
[units: percentage]
Mean ± Standard Deviation
  0.82  ± 0.39     0.85  ± 0.35     0.84  ± 0.43     0.83  ± 0.39  
[1] 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.



  Outcome Measures
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1.  Primary:   Peak Methemoglobin Blood Levels   [ Time Frame: Measured at 10 second intervals during dental treatment for an average of 2 hours ]

2.  Secondary:   Time to Peak Methemoglobin Blood Levels   [ Time Frame: Measured at 10 second intervals during dental treatment for an average of 2 hours ]

3.  Secondary:   Delta Methemoglobin Blood Level   [ Time Frame: 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Lauren Gutenberg
Organization: Loma Linda University
phone: 909-558-4690
e-mail: 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


Responsible Party: Lauren GutenBerg, Loma Linda University
ClinicalTrials.gov Identifier: NCT01402869     History of Changes
Other Study ID Numbers: 5110172
Study First Received: July 25, 2011
Results First Received: October 15, 2013
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board