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Effect of Buffered Numbing Solution on Patients With Toothaches

Primary Purpose

Irreversible Pulpitis (Toothache)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

buffered lidocaine

nonbuffered lidocaine

About this trial

This is an interventional treatment trial for Irreversible Pulpitis (Toothache)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with a diagnosis of irreversible pulpitis (toothache) in a mandibular posterior tooth (back/bottom tooth) with moderate to severe pain
ages 18 -65 years of age
in good health (ASA I or II)
able to grant informed consent.

Exclusion Criteria:

allergy to lidocaine (numbing solution
significant medical problem (ASA III or IV)
have taken CNS depressants or analgesic medications within the last 24 hours
pregnancy or lactating
non-English speaking
inability to give informed consent

Sites / Locations

The Ohio State University College of Dentistry, Postle Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

buffered lidocaine

nonbuffered lidocaine

Arm Description

4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.

4% lidocaine with 1:100,000 epinephrine

Outcomes

Primary Outcome Measures

Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)

Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.

100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm.

Secondary Outcome Measures

Full Information

NCT ID

NCT01868776

First Posted

May 30, 2013

Last Updated

September 14, 2020

Sponsor

Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT01868776

Brief Title

Effect of Buffered Numbing Solution on Patients With Toothaches

Official Title

Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Patients presenting with toothaches will be given either a buffered numbing solution or a nonbuffered numbing solution. Neither the patient nor the operator will know which solution they will receive. Root canal treatment will be performed on the tooth and the ability of the buffered versus non-buffered numbing solutions will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irreversible Pulpitis (Toothache)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

buffered lidocaine

Arm Type

Experimental

Arm Description

4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.

Arm Title

nonbuffered lidocaine

Arm Type

Active Comparator

Arm Description

4% lidocaine with 1:100,000 epinephrine

Intervention Type

Drug

Intervention Name(s)

buffered lidocaine

Intervention Type

Drug

Intervention Name(s)

nonbuffered lidocaine

Primary Outcome Measure Information:

Title

Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)

Time Frame

pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection

Title

Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.

Description

Time Frame

approximately 15 minutes after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with a diagnosis of irreversible pulpitis (toothache) in a mandibular posterior tooth (back/bottom tooth) with moderate to severe pain ages 18 -65 years of age in good health (ASA I or II) able to grant informed consent. Exclusion Criteria: allergy to lidocaine (numbing solution significant medical problem (ASA III or IV) have taken CNS depressants or analgesic medications within the last 24 hours pregnancy or lactating non-English speaking inability to give informed consent

Facility Information:

Facility Name

The Ohio State University College of Dentistry, Postle Hall

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

3717616

Citation

DiFazio CA, Carron H, Grosslight KR, Moscicki JC, Bolding WR, Johns RA. Comparison of pH-adjusted lidocaine solutions for epidural anesthesia. Anesth Analg. 1986 Jul;65(7):760-4.

Results Reference

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PubMed Identifier

2008283

Citation

Zahl K, Jordan A, McGroarty J, Sorensen B, Gotta AW. Peribulbar anesthesia. Effect of bicarbonate on mixtures of lidocaine, bupivacaine, and hyaluronidase with or without epinephrine. Ophthalmology. 1991 Feb;98(2):239-42. doi: 10.1016/s0161-6420(91)32311-x.

Results Reference

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PubMed Identifier

11020760

Citation

Sinnott CJ, Garfield JM, Thalhammer JG, Strichartz GR. Addition of sodium bicarbonate to lidocaine decreases the duration of peripheral nerve block in the rat. Anesthesiology. 2000 Oct;93(4):1045-52. doi: 10.1097/00000542-200010000-00028.

Results Reference

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PubMed Identifier

7629414

Citation

Richtsmeier AJ, Hatcher JW. Buffered lidocaine for skin infiltration prior to hemodialysis. J Pain Symptom Manage. 1995 Apr;10(3):198-203. doi: 10.1016/0885-3924(94)00124-4.

Results Reference

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PubMed Identifier

16384767

Citation

Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.

Results Reference

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PubMed Identifier

1314142

Citation

Ackerman WE 3rd, Ware TR, Juneja M. The air-liquid interface and the pH and PCO2 of alkalinized local anaesthetic solutions. Can J Anaesth. 1992 Apr;39(4):387-9. doi: 10.1007/BF03009051.

Results Reference

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Effect of Buffered Numbing Solution on Patients With Toothaches

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