Use of Tramadol Intraligamentary Injections
Condition: Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      Introduction: To achieve painless treatment in patients with a failed primary IANB,
      supplementary anaesthesia has been advised. The majority of the studies evaluating
      intraligamentary injections have been performed on asymptomatic teeth. Very limited research
      has been dedicated to the evaluation of different variables in intraligamentary injections in
      patients with symptomatic irreversible pulpitis Aim: To evaluate the anaesthetic efficacy of
      2% lidocaine with 1:80 000 epinephrine vs. 2% lidocaine with 1:80 000 epinephrine plus
      tramadol hydrochloride (50 mg, 1:1 v/v ratio), given as intraligamentary injections after a
      failed inferior alveolar nerve block (IANB), in patients with symptomatic irreversible
      pulpitis. Objective: 1. To achieve painless treatment in patients with a failed primary IANB.
      during the endodontic management of symptomatic mandibular first/second molar. 2. To evaluate
      the heart rate during and after intraligamentary injections Methods: This prospective,
      randomized, double-blind clinical trial will be carried out by Conservative Dentistry,
      Faculty Of Dentistry, Jamia Millia Islamia. Sixty adult patients with symptomatic
      irreversible pulpits in a mandibular first or second molar will receive an initial IANB with
      2% lidocaine with 1:80 000 epinephrine. Pain during the endodontic treatment will be assessed
      using a visual analogue scale(VAS). Patients experiencing pain on endodontic intervention
      shall be randomly allocated to one of the two treatment groups: one group shall receive 0.6
      mL/ root of supplementary intraligamentary injection of 2% lidocaine with 1:80 000
      epinephrine; while the second group shall receive 2% lidocaine with 1:80 000 epinephrine plus
      tramadol hydrochloride (50 mg, 1:1 v/v ratio). Endodontic treatment will be re-initiated.
      Success after primary injection or supplementary injection will be defined as no or mild pain
      (less than 55 mm on HP VAS) during access preparation and root canal instrumentation. Heart
      rate will be monitored using a finger pulse oximeter by a faculty member. Statistical
      analysis: The results will be tabulated in contingency tables. The anaesthetic success rates
      will be analyzed with the Pearson chi-square test at 5% significance levels. The heart rate
      changes will be analyzed using a t-test.
    

Detailed description: 
      Patients experiencing a failed primary IANB shall be enrolled in the study. The initial
      failure will be defined as pain (score more than 54 on Heft Parker Visual Analog Scale (VAS)
      during access cavity preparation or at the root canal instrumentation stage. The primary
      outcome (endpoint) will be defined as "success or failure, " indicating the ability to
      undertake pulp access and canal instrumentation with no or mild pain. The secondary outcome
      will be the evaluation of heart rate after supplementary intraligamentary injections.

      A tentative sample size calculation has been performed using data from a previous study,
      keeping the α level type I error at 0.05 for a single-tailed test and β level type II error
      at 0.20.19 The analysis indicated that a sample size of 35 subjects would give 80% power to
      detect a 30% difference in the success rates of the two different supplemental
      intraligamentary injections. For heart rate analysis, it has been calculated that a minimum
      of 23 patients per group shall be required to detect a difference of 10 beats per minute
      (with a baseline heart rate of 72 beats per minute).

      The treatment procedure and the use of pain scales will be explained to the patients. A
      combined VAS, the Heft-Parker scale (HP VAS), will be used in the present study.

      All patients will receive a primary IANB injection using 1.8 mL of 2% lidocaine with 1: 80
      000 epinephrine using a direct Halsted approach. The needle will be inserted until bony
      resistance will be felt. After reaching the target area, aspiration will be performed, and
      the solution will be deposited over a period of 60 seconds. After 10 minutes, the patients
      will be asked about lip numbness. Patients without profound lip numbness will be excluded
      from the study since the block will be considered 'missed'. A conventional access opening
      will be initiated after isolation with a rubber dam. Patients will be instructed to raise
      their hands if any pain will be felt during the procedure. In case of pain during treatment,
      the procedure will be stopped, and the patients will be asked to rate the pain on the HP VAS.
      The patients with failed primary IANB will receive supplementary intraligamentary injections
      of either 2% lidocaine with 1:80 000 epinephrine or 2% lidocaine with 1:80 000 epinephrine
      plus tramadol hydrochloride (50 mg, 1:1 v/v ratio) or tramadol hydrochloride (25mg/mL). The
      cartridges will be masked with an opaque tape and coded with an alpha-numeric code. The code
      will be broken only after the completion of the study. The patients will be randomly
      allocated to three treatment groups (n=105, 35 patients per group) with the help of an online
      random generator. The rubber dam will be removed and the injection site will be cleaned with
      an antiseptic solution. The resting heart rate will be monitored with a finger pulse oximeter
      by a faculty member. The first group will receive intraligamentary injections of 2% lidocaine
      with 1: 80 000 epinephrine. The injections will be administered using a pressure-type syringe
      (Osung Deosy, Pearland, Tx, USA) and 30 gauge short needles (Septojet needles, Septodont).
      The second group will receive intraligamentary injections of 2% lidocaine with 1:80 000
      epinephrine plus tramadol hydrochloride (50 mg, 1:1 v/v ratio). The third group shall receive
      intraligamentary injections of tramadol hydrochloride (25mg/ mL). A total of 1.2 mL of
      anaesthetic solution will be deposited. The heart rate will be measured at 15-second
      intervals till 5 minutes after intraligamentary injections. Success will be again defined as
      no pain or faint/weak/mild pain during endodontic access preparation and instrumentation.

      Statistical analysis: The results will be tabulated in contingency tables. The age of
      patients will be analyzed using the Mann-Whitney U test at P < .05. The gender and
      distribution of teeth will be analyzed using 2X2 contingency tables and chi-square tests. The
      anaesthetic success rates will be analyzed with the Pearson chi-square test. The heart rate
      changes will be analyzed using a t-test.
    

Intervention name(s): Tramadol hydrochloride; Lidocaine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Supplementary intraligamentary injections deposited in the gingival sulcus of the involved tooth; Supplementary intraligamentary injections deposited in the gingival sulcus of the involved tooth
Intervention MeSH terms: Lidocaine; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment