Effect of Buffered Numbing Solution on Patients With Toothaches

NCT01868776 | Completed Results

• 1 other identifier: buffered anesthetic toothache
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis (Toothache)

Outcome Measures

Primary Outcomes (2)

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

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

• 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.

  approximately 15 minutes after injection

Study Arms (2)

buffered lidocaine

EXPERIMENTAL

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

Drug: buffered lidocaine

nonbuffered lidocaine

ACTIVE COMPARATOR

4% lidocaine with 1:100,000 epinephrine

Drug: nonbuffered lidocaine

Interventions

buffered lidocaine DRUG

buffered lidocaine

nonbuffered lidocaine DRUG

nonbuffered lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, 43210, United States

Location

Related Publications (6)

• 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.

  PMID: 3717616 BACKGROUND

• 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.

  PMID: 2008283 BACKGROUND

• 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.

  PMID: 11020760 BACKGROUND

• 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.

  PMID: 7629414 BACKGROUND

• 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.

  PMID: 16384767 BACKGROUND

• 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.

  PMID: 1314142 BACKGROUND

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Melissa Drum
• Organization: The Ohio State University

drum.13@osu.edu

6142923596

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 5, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 6, 2020
• Results First Posted: May 29, 2015

Record last verified: 2020-09

Locations

US (1)