Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain

Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Drug: Tramadol; Drug: Naproxen Sodium; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Dow International Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASA I and ASA II individuals who are between the ages of 18 and 60 years.
• Patients who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
• Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS= 1-10).
• Mandibular permanent premolar and molars.

Exclusion Criteria:

• Patients who had taken painkillers or narcotics in the previous 12 hours
• Patients suffering from severe pain because of traumatic occlusion.
• Teeth with extensive damage, calcified canals, root resorption, and an open apex.
• Previously root canal treated teeth.
• Medically compromised patients (ASA-III and above)
• Those with special communication needs or who do not understand Urdu or English language.
• Pregnant and lactating women
• Individual patients who will be driving back alone
• Patients who are allergic to the prescribed medicines

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tramadol; Group A will receive premedication of Oral tramadol 100mg,	Drug: Tramadol; Tramadol 100mg will be given 60 minutes before start of procedure.; Other Names: Tramal tablet
Active Comparator: Naproxen Sodium; Group B will receive premedication of oral naproxen sodium 550mg.	Drug: Naproxen Sodium; Naproxen sodium 550mg will be given 60 minutes before start of procedure.; Other Names: Synflex 550mg
Placebo Comparator: Placebo; Group C, will be the control group and no active preoperative medication will be given to these patients.	Drug: Placebo; Placebo will be given 60 minutes before start of procedure.; Other Names: Surbex Z

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Anesthesia Efficacy	Change in pain will be assessed after administration of inferior alveolar nerve block and during access opening on a visual analogue scale of 0-10 ," 0 being no pain", "10 being worst pain"	10minutes,20minutes
Postoperative pain	Change in pain will be assessed after cleaning and shaping till #25 k file on a visual analogue scale of 0-10, "0 being no pain and 10 being worst pain"	6 hours, 24 hours,48 hours, 72hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects of Medications	Nausea, Headache, Dizziness, Vertigo will be recorded as experienced or not experienced	6hours, 24hours

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Tayyaba Tahira, BDS FCPS, Dow International Dental College, Dow University of Health Sciences; Study Director: Farah Naz, BDS FCPS, Dow International Dental College, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: August 5, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Placebo; Tramadol; Naproxen Sodium
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Pulpitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Gout Suppressants; Tramadol; Naproxen
• Other Study ID Numbers: 2889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Only investigators and co-investigators of this study will be able to access to participants' personal data.

Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No