Clinical trial NCT01868776: 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
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis (Toothache)
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)
timeFrame: pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection
measure: Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.
timeFrame: approximately 15 minutes after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Dentistry, Postle Hall
state: Ohio
Study officials:
References:
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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.
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.