CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Sodium bicarbonate +1 moredrug
Likely dose
2% lidocaine with 1:100,000 ppm epinephrine (with or without 8.4% sodium bicarbonate buffering)AI-extracted
Key inclusion· 4
  • Age 9-12 years
  • Able to understand visual and verbal pain rating scales
  • Moderate mandibular dental disease bilaterally with 4-7 natural teeth per quadrant
  • Willing to attend 3+ clinic appointments
Key exclusion· 9
  • Allergy or sensitivity to amide local anesthetics or epinephrine
  • Systemic illness precluding local anesthetic or epinephrine use (liver, renal, cardiovascular disease, blood dyscrasias, psychiatric disorders)
  • Systemic illness interfering with healing (liver disease, blood dyscrasias, uncontrolled diabetes)
  • Current systemic medication interfering with healing or contraindicating local anesthetics/epinephrine

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01622296
NCT01622296Phase 4Completed

Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients. A Prospective, Double-blind, Randomized, Crossover Study

University of California, San Francisco·interventional·Posted Jun 19, 2012·Updated Mar 17, 2014

In Brief

A Phase 4 clinical trial evaluating Sodium bicarbonate and Lidocaine for Pain. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effectiveness of buffered local anesthesia injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine with sodium bicarbonate may reduce the pain of injection for both adults and children. In this study, the investigators will compare two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection. Hypothesis: Anesthetic buffered to physiologic pH will result in a less painful injection compared to the acidic alternative used in most dental offices. This can be demonstrated by comparing two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2012
Enrollment StartApr 1, 2012
Primary CompletionJul 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.0 years ago

Interventions

Sodium bicarbonatedrug

8.4% neutralizing solution

Lidocainedrug

2% lidocaine with 1:100,000 ppm epinephrine