Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain

NCT05982392 | Completed Phase 2 Results

• 1 other identifier: 2889
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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 molar 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.

Conditions

Symptomatic Irreversible Pulpitis; Post Operative Pain

Keywords

Tramadol; Naproxen Sodium; Placebo

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Local Anesthesia Efficacy

  Local anesthesia efficacy was defined as absence of pain (VAS score ≤ 3) during access cavity preparation (deroofing) after inferior alveolar nerve block. Pain was assessed using a 10-point Visual Analog Scale (0 = no pain, 10 = worst pain). Participants were categorized as having successful anesthesia if VAS ≤ 3 and failure if VAS \> 3.

  During access cavity preparation (deroofing)

Secondary Outcomes (1)

• Postoperative Pain

  6,24,48,72 hours post operatively

Study Arms (3)

Tramadol

ACTIVE COMPARATOR

Group A will receive premedication of Oral tramadol 100mg,

Drug: Tramadol

Naproxen Sodium

ACTIVE COMPARATOR

Group B will receive premedication of oral naproxen sodium 550mg.

Drug: Naproxen Sodium

Placebo

PLACEBO COMPARATOR

Group C, will be the control group, and Surbex-Z will be given to these patients.

Drug: Placebo

Interventions

Tramadol DRUG

Tramadol 100mg will be given 60 minutes before start of procedure.

Also known as: Tramal tablet

Tramadol

Naproxen Sodium DRUG

Naproxen sodium 550mg will be given 60 minutes before start of procedure.

Also known as: Synflex 550mg

Naproxen Sodium

Placebo DRUG

Placebo will be given 60 minutes before start of procedure.

Also known as: Surbex Z

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 molars.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow International Dental College

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Naproxen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

1. use of multivitamin as placebo 2. only SIP patients included 3. limited power sample small size

Results Point of Contact

• Title: Farah Naz
• Organization: Dow university of health sciences

farah.naz@duhs.edu.pk

03323461321

Study Officials

• Tayyaba Tahira, BDS FCPS

  Dow International Dental College, Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Farah Naz, BDS FCPS

  Dow International Dental College, Dow University of Health Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Clinician and participants both will be blind to the medicine given to the participants. Participants will be given identical capsules by paramedical staff will be trained in giving medication to the participants. Outcome Assessor will be an intern who is not on research.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The participants will be randomly divided into 3 groups. Computer software (Microsoft Excel, Redmond, WA) will be used to generate a random patient allocation sequence. 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.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 8, 2023
• Study Start: March 1, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: June 25, 2026
• Results First Posted: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)