Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain
Condition: Symptomatic Irreversible Pulpitis; Post Operative Pain
MeSH terms: Pulpitis; Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this clinical trial is to compare in Tramadol, Naproxen sodium and Placebo in
      participants presenting with irreversible pulpitis in their mandibular posterior teeth.

      The main question[s] it aims to answer are:

        -  Local anesthetic efficacy and .

        -  Postoperative pain. Participants will receive premedication treatments 60 minutes prior
           to the local anesthesia administration.

      Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on
      Inferior alveolar nerve block efficacy and Postoperative pain.
    

Detailed description: 
      The adult participants who report in out-patient department (OPD) of Operative Dentistry at
      Dow International Dental College with the symptoms of irreversible pulpitis will be screened
      for the participation in the study. A detailed history will be taken which will be followed
      by clinical examination and complemented with sensibility testing with Endo Ice or electric
      pulp test. Radiographic analysis will also be done to confirm the diagnosis to assess for
      factors pertaining to exclusion and inclusion criteria. Verbal and written informed consent
      will be taken from all the participants.

      Randomization: The participants will be randomly divided into 3 groups by envelope method.

      Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication
      of oral naproxen 550mg. Both medicines will be given 60 minutes prior to the local anesthesia
      administration. The third group, Group C, will be the control group and no active
      preoperative medication will be given to these participants. A placebo will be given to these
      participants. These medications will be given as a single intervention only.

      Blinding: Clinician and participants both will be blind to the medicine given to the
      participants. Participants will be allowed to pick envelopes and a paramedical staff will be
      trained in giving medication to the participants.

      Pain scores will be recorded by asking the participant to rate their pain on a scale ranging
      from 0 to 10 before medication and then after 15 minutes, 30 minutes and 60 minutes of
      administering the premedication. Pain score will also be recorded after 10 minutes of the
      administration of Inferior alveolar nerve block (IANBs) and buccal nerve block & during
      deroofing process of chamber opening.

      Two cartridges of Lidocaine 1.8 ml having a concentration of 1:100,000 of Epinephrine will be
      used for administration of regional anesthesia. Access opening will be performed under rubber
      dam isolation with a Mani number 245 bur in a high-speed hand piece with copious water
      irrigation. Sodium hypochlorite (5.25%) will be used as a standard root canal irrigation
      solution.Pulpectomy will be performed with Mani K-files (8-25) till respective working
      lengths of the teeth under study.

      To assess the post-operative pain, a proforma and pain intensity scale will be provided to
      the participants for self recording at 6, 24, 48 and 72 hours after the procedure. The
      participants will return the proforma to an intern on 3rd day to be assessed by an intern
      supervised by the principal investigator.

      (For this research, "The investigators will be offering As per need analgesic for
      breakthrough pain. Participants will be offered brufen 400mg as needed. The participants will
      be advised to mark breakthrough pain on VAS at the time of taking medicine).

      The participants will also be monitored for the adverse effects of these medications (nausea,
      vomiting, dizziness, drowsiness) as a secondary outcome .at above-mentioned time-intervals.
    

Intervention name(s): Tramadol; Naproxen Sodium; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tramadol 100mg will be given 60 minutes before start of procedure.; Naproxen sodium 550mg will be given 60 minutes before start of procedure.; Placebo will be given 60 minutes before start of procedure.
Other intervention name(s): Tramal tablet; Synflex 550mg; Surbex Z
Intervention MeSH terms: Naproxen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be randomly divided into 3 groups by envelope method. Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen sodium 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tramadol; Naproxen Sodium; Placebo