Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block.
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see how preoperative oral diclofenac sodium, piroxicam, and
      tramadol affects inferior alveolar nerve block efficacy during root canal treatment of
      mandibular molars with symptomatic irreversible pulpitis.

      The proposed hypothesis is that the tested drug groups will improve the efficacy of inferior
      alveolar nerve block in comparison to the control group.
    

Detailed description: 
      Standard Operating Procedure:

        -  A non-probability consecutive sampling was done in a dental out patient department and
           120 patients were included and randomly divided in the 4 groups (n=30) using simple
           randomization as per the inclusion criteria.

        -  A verbal informed consent was taken from each participant before including them in a
           group.

        -  The study was designed to be a double blinded study, where the researchers and the
           patients both were unaware of the groups of drugs that were used; this anonymity was
           achieved by marking the groups A, B, C and D on boxes for drugs containing a placebo,
           diclofenac sodium, piroxicam, and tramadol respectively.

        -  The Heft Parker Visual Analogue Scale was used to assess the patients' pain levels prior
           to the drug ingestion, and the study was continued on the patients that reported
           moderate to severe pain on the Visual Analogue Scale. On this scale, the pain
           intensities were categorized as: no pain (0), mild pain (1-54 mm), moderate pain (55-
           114 mm) and severe pain (> 114 mm).

        -  The patients were then given their respective group of drug/placebo. The patients were
           instructed to wait for 1 hour before they were administered Inferior Alveolar Nerve
           Block with 1.8 ml of 2% lidocaine with 1:100000 epinephrine using a non-aspirating
           syringe through a long needle of 27-Gauge.

        -  Standard root canal treatment was initiated after lip numbness was achieved, and pain
           levels were reassessed by Heft Parker Visual Analogue Scale during the root canal
           procedure. However, the patients who did not achieve the numbness of the lips were
           excluded from the study.

        -  Patients who reported discomfort and pain during the endodontic procedure were
           intervened appropriately; conversely, if the patient did not report any intraoperative
           pain, endodontic procedure was resumed.

        -  Till the end of the data collection process, the collected data forms were stored in a 4
           different files labeled A ,B ,C and D respective to the drug groups. On completion of
           the collection process the data was added and stored as a data file into IBM SPSS
           Statistics version 25 and further analyzed.

      Sample Size Estimation:

      The study size was calculated with reference to previous reports, revealing that at least 30
      individuals should be included as per the analysis of power of the study. The value of power
      used was 0.96, the effect size was taken as 0.4, and α was set as 0.05.

      Statistical Analysis Plan:

      Test of normality will be checked using one sample Shapiro Wilk. One-way ANOVA with Tukey's
      post-hoc will be employed if parametric test criteria is met; however if the parametric
      criteria is not fulfilled, the experimental groups will be compared using Kruskal-Wallis test
      with post-hoc analysis. The Chi-square test will be used to compare gender and drug groups
      against the Inferior Alveolar Nerve Block efficacy. These tests will be conducted on SPSS
      Statistics version 25.
    

Intervention name(s): Vitamin E; Diclofenac Sodium; Piroxicam; Tramadol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Evion, 400 mg; Voltral SR100, 100 mg; Feldene, 20 mg; Tramal, 50 mg
Intervention MeSH terms: Vitamin E; Diclofenac; Piroxicam; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The visual analogue scale was used to assess the patients' pain levels prior to the drug ingestion. The patients were then given their respective group of drug where the control group received vitamin E and three experimental groups received one tablet/capsule of diclofenac sodium (Voltral SR100, 100 mg), piroxicam (Feldene, 20 mg), and tramadol (Tramal, 50 mg). The patients were instructed to wait for 1 hour before they were administered an inferior alveolar nerve block. Standard root canal treatment was initiated after lip numbness was achieved, and pain levels were reassessed by visual analogue scale.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: inferior alveolar nerve block; irreversible pulpitis; diclofenac sodium; piroxicam; tramadol