Trial Outcomes & Findings for Effect of Buffered Numbing Solution on Patients With Toothaches (NCT NCT01868776)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

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

Results posted on

2020-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Buffered buffered lidocaine	Nonbuffered nonbuffered lidocaine
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Buffered Numbing Solution on Patients With Toothaches

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buffered n=50 Participants buffered lidocaine	Nonbuffered n=50 Participants nonbuffered lidocaine	Total n=100 Participants Total of all reporting groups
Age, Continuous	34.8 years STANDARD_DEVIATION 11.3 • n=5 Participants	35.5 years STANDARD_DEVIATION 10.7 • n=7 Participants	35.1 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Buffered Lidocaine n=50 Participants 4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate. buffered lidocaine	Nonbuffered Lidocaine n=50 Participants 4% lidocaine with 1:100,000 epinephrine nonbuffered lidocaine
Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)	16 Participants	20 Participants

PRIMARY outcome

Timeframe: approximately 15 minutes after injection

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.

Outcome measures

Outcome measures
Measure	Buffered Lidocaine n=50 Participants 4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate. buffered lidocaine	Nonbuffered Lidocaine n=50 Participants 4% lidocaine with 1:100,000 epinephrine nonbuffered lidocaine
Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.	32 percentage of participants	40 percentage of participants

Adverse Events

Buffered

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nonbuffered

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Melissa Drum

The Ohio State University

Phone: 6142923596

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place