Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics

NCT01402869 | Completed Results

• 1 other identifier: 5110172
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Methemoglobinemia

Keywords

Methemoglobin; Methemoglobinemia; Prilocaine; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Peak Methemoglobin Blood Levels

  The maximum percentage of methemoglobin in blood

  Measured at 10 second intervals during dental treatment for an average of 2 hours

Secondary Outcomes (2)

• Time to Peak Methemoglobin Blood Levels

  Measured at 10 second intervals during dental treatment for an average of 2 hours

• 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

Study Arms (3)

Prilocaine

EXPERIMENTAL

30 subjects will receive 5mg/kg of 4% prilocaine plain local anesthetic for restorative dental treatment under general anesthesia

Drug: 4% prilocaine plain

Lidocaine

EXPERIMENTAL

30 subjects will receive 2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine local anesthetic for restorative dental treatment under general anesthesia

Drug: 2% Lidocaine with 1:100,000 epinephrine

No local anesthetic

NO INTERVENTION

30 subjects will not receive local anesthetic for dental treatment under general anesthesia-Negative control

Interventions

4% prilocaine plain DRUG

5mg/kg via infiltration into multiple sites of the buccal mucosa of mouth 1 time prior to start of restorative dental treatment

Also known as: Citanest Plain

Prilocaine

2% Lidocaine with 1:100,000 epinephrine DRUG

2.5mg/kg via infiltration into multiple sites of buccal mucosa of mouth 1 time prior to restorative dental treatment

Also known as: Xylocaine

Lidocaine

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University School of Dentistry Koppel Special Care Dentistry Center

Loma Linda, California, 92350, United States

Location

Related Publications (21)

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  PMID: 10533013 BACKGROUND

• Ash-Bernal R, Wise R, Wright SM. Acquired methemoglobinemia: a retrospective series of 138 cases at 2 teaching hospitals. Medicine (Baltimore). 2004 Sep;83(5):265-273. doi: 10.1097/01.md.0000141096.00377.3f.

  PMID: 15342970 BACKGROUND

• Umbreit J. Methemoglobin--it's not just blue: a concise review. Am J Hematol. 2007 Feb;82(2):134-44. doi: 10.1002/ajh.20738.

  PMID: 16986127 BACKGROUND

• Trapp L, Will J. Acquired methemoglobinemia revisited. Dent Clin North Am. 2010 Oct;54(4):665-75. doi: 10.1016/j.cden.2010.06.007. Epub 2010 Aug 7.

  PMID: 20831930 BACKGROUND

• Malamed SF. Local anesthetics: dentistry's most important drugs, clinical update 2006. J Calif Dent Assoc. 2006 Dec;34(12):971-6.

  PMID: 17260521 BACKGROUND

• Budenz AW. Local anesthetics in dentistry: then and now. J Calif Dent Assoc. 2003 May;31(5):388-96.

  PMID: 12839231 BACKGROUND

• Moore PA, Hersh EV. Local anesthetics: pharmacology and toxicity. Dent Clin North Am. 2010 Oct;54(4):587-99. doi: 10.1016/j.cden.2010.06.015.

  PMID: 20831923 BACKGROUND

• Bader AM, Concepcion M, Hurley RJ, Arthur GR. Comparison of lidocaine and prilocaine for intravenous regional anesthesia. Anesthesiology. 1988 Sep;69(3):409-12. doi: 10.1097/00000542-198809000-00022. No abstract available.

  PMID: 3415022 BACKGROUND

• Vasters FG, Eberhart LH, Koch T, Kranke P, Wulf H, Morin AM. Risk factors for prilocaine-induced methaemoglobinaemia following peripheral regional anaesthesia. Eur J Anaesthesiol. 2006 Sep;23(9):760-5. doi: 10.1017/S0265021506000913. Epub 2006 May 24.

  PMID: 16723054 BACKGROUND

• Soeding P, Deppe M, Gehring H. Pulse-oximetric measurement of prilocaine-induced methemoglobinemia in regional anesthesia. Anesth Analg. 2010 Oct;111(4):1065-8. doi: 10.1213/ANE.0b013e3181eb6239. Epub 2010 Aug 12.

  PMID: 20705783 BACKGROUND

• Wilburn-Goo D, Lloyd LM. When patients become cyanotic: acquired methemoglobinemia. J Am Dent Assoc. 1999 Jun;130(6):826-31. doi: 10.14219/jada.archive.1999.0306.

  PMID: 10377640 BACKGROUND

• Guay J. Methemoglobinemia related to local anesthetics: a summary of 242 episodes. Anesth Analg. 2009 Mar;108(3):837-45. doi: 10.1213/ane.0b013e318187c4b1.

  PMID: 19224791 BACKGROUND

• Adams V, Marley J, McCarroll C. Prilocaine induced methaemoglobinaemia in a medically compromised patient. Was this an inevitable consequence of the dose administered? Br Dent J. 2007 Nov 24;203(10):585-7. doi: 10.1038/bdj.2007.1045.

  PMID: 18037845 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Herdevall BM, Klinge B, Persson L, Huledal G, Abdel-Rehim M. Plasma levels of lidocaine, o-toluidine, and prilocaine after application of 8.5 g Oraqix in patients with generalized periodontitis: effect on blood methemoglobin and tolerability. Acta Odontol Scand. 2003 Aug;61(4):230-4. doi: 10.1080/00016350310004106.

  PMID: 14582591 BACKGROUND

• Barker SJ, Curry J, Redford D, Morgan S. Measurement of carboxyhemoglobin and methemoglobin by pulse oximetry: a human volunteer study. Anesthesiology. 2006 Nov;105(5):892-7. doi: 10.1097/00000542-200611000-00008.

  PMID: 17065881 BACKGROUND

• Feiner JR, Bickler PE. Improved accuracy of methemoglobin detection by pulse CO-oximetry during hypoxia. Anesth Analg. 2010 Nov;111(5):1160-7. doi: 10.1213/ANE.0b013e3181f46da8. Epub 2010 Sep 14.

  PMID: 20841412 BACKGROUND

• Feiner JR, Bickler PE, Mannheimer PD. Accuracy of methemoglobin detection by pulse CO-oximetry during hypoxia. Anesth Analg. 2010 Jul;111(1):143-8. doi: 10.1213/ANE.0b013e3181c91bb6. Epub 2009 Dec 10.

  PMID: 20007731 BACKGROUND

• Ash-Bernal R, Brophy GM, Kily D. Acquired methemoglobinemia in the clinical setting: an important health issue revealed. CME Zone Special Report 2006 Nov.

  BACKGROUND

• Dentsply Pharmaceutical. 4% Citanest Plain Package Insert. York, PA.

  BACKGROUND

MeSH Terms

Conditions

Methemoglobinemia

Interventions

Prilocaine; Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

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.

Results Point of Contact

• Title: Dr. Lauren Gutenberg
• Organization: Loma Linda University

lgutenberg@llu.edu

909-558-4690

Study Officials

• Lauren L Gutenberg, DDS

  Loma Linda University Department of Pediatric Dentistry

  STUDY DIRECTOR

• Jung-Wei Chen, DDS, MS, PhD

  Loma Linda University Department of Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dental Resident

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 25, 2014
• Results First Posted: April 25, 2014

Record last verified: 2014-03

Locations

US (1)