A Phase 2/3 interventional study of Tramadol and Naproxen Sodium in Symptomatic Irreversible Pulpitis and Post Operative Pain, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Dow University of Health Sciences · Phase 2/3, Interventional, and Prevention
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:
Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on Inferior alveolar nerve block efficacy and Postoperative pain.
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 using a computer-generated randomization sequence (Microsoft Excel, Redmond, WA). The sequence was generated employing block randomization with an equal allocation ratio (1:1:1).
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: operator, participant and outcome assessor will be blinded. 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. This step will serve as our primary outcome measure as anasthesia success rate.
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 round 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 the Protaper universal file system until the 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 4th day to be assessed by an intern supervised by the principal investigator and assesed as secondary outcome of our study.
(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).
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 139 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Dow University of Health Sciences is the lead sponsor of 170 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group A will receive premedication of Oral tramadol 100mg,
Drug: Tramadol
Group B will receive premedication of oral naproxen sodium 550mg.
Drug: Naproxen Sodium
Group C, will be the control group, and Surbex-Z will be given to these patients.
Drug: Placebo
Tramadol 100mg will be given 60 minutes before start of procedure.
Also known as: Tramal tablet
Naproxen sodium 550mg will be given 60 minutes before start of procedure.
Also known as: Synflex 550mg
Placebo will be given 60 minutes before start of procedure.
Also known as: Surbex Z
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.
Time frame: During access cavity preparation (deroofing)
Postoperative Pain
Postoperative pain was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain intensity. Pain scores were recorded at 6, 24, 48, and 72 hours postoperatively. Results are presented as median pain scores at each time point.
Time frame: 6,24,48,72 hours post operatively
| Milestone | Tramadol | Naproxen Sodium | Placebo |
|---|---|---|---|
| Started | 40 | 40 | 40 |
| Completed | 40 | 40 | 40 |
| Not completed | 0 | 0 | 0 |
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.
| Participants | Tramadol | Naproxen Sodium | Placebo |
|---|---|---|---|
| Number of Participants With Local Anesthesia Efficacy | 34 | 24 | 10 |
Postoperative pain was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain intensity. Pain scores were recorded at 6, 24, 48, and 72 hours postoperatively. Results are presented as median pain scores at each time point.
| score on scale | Tramadol | Naproxen Sodium | Placebo |
|---|---|---|---|
| 6 hours post operative pain score | 2.5 (0 to 9) | 0.5 (0 to 7) | 4.5 (2 to 20) |
| 24 hours post operative pain score | 2.0 (0 to 10) | 0.0 (0 to 8) | 4.0 (1 to 10) |
| 48 hours post operative pain score | 1.0 (0 to 10) | 0.0 (0 to 9) | 1.5 (0 to 10) |
| 72 hours post operative pain score | 0.0 (0 to 7) | 0.0 (0 to 4) | 2.0 (0 to 8) |
Collected over 3 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tramadol | 0/40 (0%) | 0/40 (0%) | 8/40 (20%) |
| Naproxen Sodium | 0/40 (0%) | 0/40 (0%) | 1/40 (2.5%) |
| Placebo | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Event | Tramadol | Naproxen Sodium | Placebo |
|---|---|---|---|
| NauseaGeneral disorders | 8/40 | 1/40 | 0/40 |
| Age, Continuous(Years) | Tramadol | Naproxen Sodium | Placebo | Total |
|---|---|---|---|---|
| Median | 30.0 (18 to 42) | 34.5 (22 to 50) | 28.0 (24 to 46) | 31.25 (18 to 50) |
| Sex: Female, Male(Participants) | Tramadol | Naproxen Sodium | Placebo | Total |
|---|---|---|---|---|
| Female | 28 | 22 | 26 | 76 |
| Male | 12 | 18 | 14 | 44 |
| Race and Ethnicity Not Collected(Participants) | Tramadol | Naproxen Sodium | Placebo | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Preoperative pain scores on VAS(score on scale) | Tramadol | Naproxen Sodium | Placebo | Total |
|---|---|---|---|---|
| Median | 8.0 (6 to 10) | 8.5 (6 to 10) | 8 (5 to 10) | 8 (5 to 10) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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