Trial Outcomes & Findings for Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain (NCT NCT05982392)
NCT ID: NCT05982392
Last Updated: 2026-06-25
Results Overview
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.
COMPLETED
PHASE2/PHASE3
139 participants
During access cavity preparation (deroofing)
2026-06-25
Participant Flow
Of 145 eligible patients, 139 consented to participate in the study and to undergo the anesthetic and endodontic procedures. However, only 120 patients were evaluated for anesthetic efficacy and postoperative pain. This was due to 12 patients not recording VAS readings, 2 being excluded after access cavity preparation because of a lack of bleeding to confirm pulp vitality, and 5 requiring rescue medication after root canal treatment. Consequently, data from 120 patients were analyzed (Figure 1).
Participant milestones
| Measure |
Tramadol
Group A will receive premedication of Oral tramadol 100mg,
|
Naproxen Sodium
Group B will receive premedication of oral naproxen sodium 550mg.
|
Placebo
Group C, will be the control group, and Surbex-Z will be given to these patients.
|
|---|---|---|---|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tramadol
n=40 Participants
Group A will receive premedication of Oral tramadol 100mg,
|
Naproxen Sodium
n=40 Participants
Group B will receive premedication of oral naproxen sodium 550mg.
|
Placebo
n=40 Participants
Group C, will be the control group, and Surbex-Z will be given to these patients.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.0 Years
n=40 Participants
|
34.5 Years
n=40 Participants
|
28.0 Years
n=40 Participants
|
31.25 Years
n=120 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=40 Participants
|
22 Participants
n=40 Participants
|
26 Participants
n=40 Participants
|
76 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=40 Participants
|
18 Participants
n=40 Participants
|
14 Participants
n=40 Participants
|
44 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Preoperative pain scores on VAS
|
8.0 score on scale
n=40 Participants
|
8.5 score on scale
n=40 Participants
|
8 score on scale
n=40 Participants
|
8 score on scale
n=120 Participants
|
PRIMARY outcome
Timeframe: During access cavity preparation (deroofing)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.
Outcome measures
| Measure |
Tramadol
n=40 Participants
Group A will receive premedication of Oral tramadol 100mg,
|
Naproxen Sodium
n=40 Participants
Group B will receive premedication of oral naproxen sodium 550mg.
|
Placebo
n=40 Participants
Group C, will be the control group, and Surbex-Z will be given to these patients.
|
|---|---|---|---|
|
Number of Participants With Local Anesthesia Efficacy
|
34 Participants
|
24 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6,24,48,72 hours post operativelyPostoperative 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.
Outcome measures
| Measure |
Tramadol
n=40 Participants
Group A will receive premedication of Oral tramadol 100mg,
|
Naproxen Sodium
n=40 Participants
Group B will receive premedication of oral naproxen sodium 550mg.
|
Placebo
n=40 Participants
Group C, will be the control group, and Surbex-Z will be given to these patients.
|
|---|---|---|---|
|
Postoperative Pain
24 hours post operative pain score
|
2.0 score on scale
Interval 0.0 to 10.0
|
0.0 score on scale
Interval 0.0 to 8.0
|
4.0 score on scale
Interval 1.0 to 10.0
|
|
Postoperative Pain
48 hours post operative pain score
|
1.0 score on scale
Interval 0.0 to 10.0
|
0.0 score on scale
Interval 0.0 to 9.0
|
1.5 score on scale
Interval 0.0 to 10.0
|
|
Postoperative Pain
6 hours post operative pain score
|
2.5 score on scale
Interval 0.0 to 9.0
|
0.5 score on scale
Interval 0.0 to 7.0
|
4.5 score on scale
Interval 2.0 to 20.0
|
|
Postoperative Pain
72 hours post operative pain score
|
0.0 score on scale
Interval 0.0 to 7.0
|
0.0 score on scale
Interval 0.0 to 4.0
|
2.0 score on scale
Interval 0.0 to 8.0
|
Adverse Events
Tramadol
Naproxen Sodium
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tramadol
n=40 participants at risk
Group A will receive premedication of Oral tramadol 100mg,
|
Naproxen Sodium
n=40 participants at risk
Group B will receive premedication of oral naproxen sodium 550mg.
|
Placebo
n=40 participants at risk
Group C, will be the control group, and Surbex-Z will be given to these patients.
|
|---|---|---|---|
|
General disorders
Nausea
|
20.0%
8/40 • 3 days
Participants were followed for a period of 3 days postoperatively for monitoring of adverse effects. Adverse effects were actively assessed, including Nausea, vomiting, dizziness, and headache.
|
2.5%
1/40 • 3 days
Participants were followed for a period of 3 days postoperatively for monitoring of adverse effects. Adverse effects were actively assessed, including Nausea, vomiting, dizziness, and headache.
|
0.00%
0/40 • 3 days
Participants were followed for a period of 3 days postoperatively for monitoring of adverse effects. Adverse effects were actively assessed, including Nausea, vomiting, dizziness, and headache.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place