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Completed

NCT Number: NCT03562481

Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years

Local anesthesia is an integral part of clinical pediatric dental practice, but it has challenges. It can be uncomfortable for children, and the risk of adverse events limits how much is used. Some evidence suggests benefits of buffering local anesthetics including equal effect with less pain on injection. These findings have not been replicated and validated among pediatric populations, creating a gap in the knowledge base. To address this knowledge gap and contribute to the evidence base on safety and efficacy of local anesthesia in pediatric dentistry, this investigation proposes to compare the anesthetic effects of buffered 1% lidocaine with those of unbuffered 2%, among children.

The specific aims of this investigation are to determine differences between buffered 1% and unbuffered 2% lidocaine (both with 1:100,000 epinephrine) used for inferior alveolar nerve block (IAN) anesthesia, in the following domains:

1. Pain experience on injection, time to onset following the administration, and time to recovery [subjective] 2. Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia [objective]

Null Hypotheses:

1. No difference exists in anesthetic effectiveness for pulpal anesthesia after intraoral IAN block between buffered 1% Lidocaine with 1:100,000 epinephrine as compared to unbuffered 2% Lidocaine with 1:100,000 epinephrine. 2. No differences exist in peak blood lidocaine levels, pain on injection, time to lip numbness, and duration of anesthesia between the two drug formulations.

Randomized subjects will be injected orally for bottom jaw anesthesia, with 3cc of buffered 1% lidocaine (30mg) 1:100,000 epinephrine or 3cc unbuffered of 2% lidocaine (60mg) 1:100,000 epinephrine. The injectable volume of the buffered formulation will include 0.3cc of 8.4% sodium bicarbonate.

One faculty member in the Department of Pediatric Dentistry at the University of North Carolina (UNC) School of Dentistry will administer the drugs in the Pediatric Dentistry clinic. The same clinician will administer injection to the same subjects at both visits. Clinicians and subjects will not know which drug formulation is given at which appointment.

A clinician will measure the level of discomfort on injection, how long it takes for the lip to be numb, how long it takes for the first molar tooth in that area to be numb, how long it takes the local anesthetic to wear off, and how much of the anesthetic is in the blood.

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Key information

Conditions

Anesthesia, Local Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNC School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10-12 years
  • American Society of Anesthesiologists (ASA) Class I (Healthy)
  • Body Weight: the Interquartile Range (IQR) 33-60Kg for subject ages
  • Have ability to speak and read English
  • Willingness to participate in two sessions
  • No history of adverse reaction to dental anesthetic
  • Have bilateral, disease/symptom-free mandibular first molars present

Exclusion criteria

  • Allergy to lidocaine class of anesthetic drugs
  • Local anesthetic drug use in past week
  • Current symptomatic teeth or oral mucosa
  • ASA II or above (including asthma)

Treatment and study plan

1% Buffered Lidocaine 1:100,000 Epinephrine

Drug

A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.

Other names: Xylocaine

2% Unbuffered Lidocaine 1:100,000 Epinephrine

Drug

A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.

Other names: Xylocaine

Primary outcomes

  1. Mean Pain Scores Following Injection

    Time frame: Within 10 minutes of injection

    Perceived pain on injection, self-reported verbally using a Likert scale from 1-10, with lower numbers corresponding to less pain (1 = "no pain," 10 = "worst pain imaginable"). Lower scores reflect a lesser degree of pain.

  2. Mean Time to Lower Lip Numbness Following Injection

    Time frame: Up to 30 minutes following injection

    Time in minutes beginning immediately following injection to patient-reported lip numbness

  3. Average Serum Lidocaine Concentration at 15 Minutes Post Injection

    Time frame: One blood draw taken 15 minutes following injection

    Blood Lidocaine Level (mcg/mL) as measured in 10cc venous blood, taken 15 minutes following injection. Blood assayed for serum lidocaine levels with a Sciex TripleTOF liquid chromatography- mass spectrometry (LC-MS) equipped with a C18 Hypersil (10mm x 2.1mm, 3.0μm).

  4. Mean Time to Baseline Lip Sensation

    Time frame: Within 24 hours following injection

    Response in minutes from injection to when lip is no longer numb, as self reported by patient.

  5. Number of Participants Who Respond to Cold Stimulus (Positive/Negative) Prior to Injection

    Time frame: 5 minutes prior to injection

    Response to experiencing sensation to cold stimulus on permanent molar tooth prior to injection

  6. Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 30 Minutes Following Injection

    Time frame: 30 minutes following injection

    Response to experiencing sensation to cold stimulus on permanent molar tooth 30 minutes following injection

  7. Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 60 Minutes Following Injection

    Time frame: 60 minutes following injection

    Response to experiencing sensation to cold stimulus on permanent molar tooth 60 minutes following injection

  8. Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 90 Minutes Following Injection

    Time frame: 90 minutes following injection

    Response to experiencing sensation to cold stimulus on permanent molar tooth 90 minutes following injection

  9. Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 120 Minutes Following Injection

    Time frame: 120 minutes following injection

    Response to experiencing sensation to cold stimulus on permanent molar tooth 120 minutes following injection

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Pilot Study: Comparison of Buffered 1% vs. Unbuffered 2% Lidocaine in Pediatric Subjects; Clinical Outcomes

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2018
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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