Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars
Condition: Local Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children
      aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis.
      The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate
      8.4% at a ratio of 1/10, as opposed to the control agent, which was non- buffered 2%
      lidocaine with 1:80,000 epinephrine. The pain will be assessed during inferior alveolar nerve
      block injection (IANB) and the effectiveness of anesthesia using the subjective Wong-Baker
      visual analog scale, the objective sound, eye, and motor (SEM) scale, and the physiological
      pain scale (pulse rate) using a pulse oximeter. The investigator has confirmed the onset of
      anesthesia after lip tongue-numbing by probing the gingiva until there is no pain. Endo-ice
      has been used to assess the onset of pulp anesthesia.
    

Detailed description: 
      In a prospective, randomized clinical trial and triple-blind, split mouth study, 40 children
      aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis.
      Random numbers between 1 to 40 were assigned to patients, with some receiving buffered
      lidocaine at their initial appointment while others received unbuffered lidocaine. The
      solutions have been switched up for the second session, which has been set for one week
      later. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium
      bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, non-buffering 2%
      lidocaine with 1:80,000 epinephrine. Buffered lidocaine has been freshly prepared by mixing
      sodium bicarbonate (8.4%) with the anaesthetic solution (lidocaine 2% with epinephrine
      1/80.000) in a 1:10 ratio by volume. Two percent benzocaine gel is applied at the injection
      site for one minute before inferior alveolar nerve block injection (IANB). The investigator
      has assessed pain during IANB injection using the subjective Wong-Baker visual analogue
      scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale
      (pulse rate) using a pulse oximeter. After administering the IANB injection, the investigator
      has confirmed the onset of anaesthesia after lip and tongue numbing by probing the gingiva
      every 30 seconds until there is no pain. Endo-ice has been used to assess the onset of pulp
      anaesthesia every 30 seconds. The effectiveness of anaesthesia has been assessed during the
      preparation of the pulp chamber using subjective, objective, and physiological pain scales.
      Finally, the numerical data will be statistically analysed, and any statistically significant
      values will be investigated.
    

Intervention name(s): Buffered lidocaine in inferior alveolar nerve block injection; lidocaine 2% in inferior alveolar nerve block injection
Intervention type(s): Combination Product; Drug
Intervention description(s): Buffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars; Lidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars
Other intervention name(s): Buffered lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This clinical research aims to evaluate the effectiveness of buffered lidocaine in the treatment of bilateral primary molars
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Buffered lidocaine