Trial · NCT04018612
A Study of Acetaminophen for Post Surgical Dental Pain
NCT04018612, Phase 2, Completed, Nevakar, Inc.; results first posted 2022-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Acetaminophen for Post Surgical Dental Pain. Trials, record NCT04018612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04018612
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Acetaminophen for Post Surgical Dental Pain
- NCT number
- NCT04018612
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- Nevakar, Inc.
- Conditions
- Pain, Postoperative, Dental Pain
- Interventions
- Acetaminophen, Placebo
- First posted
- 2019-07-12
- Last updated
- 2022-03-29
- Results first posted
- 2022-03-29
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours | Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). Time weighted sum of pain intensity difference from 0 to 24 hours was reported. Pain Intensity (PI-NPRS) was collected at initiation of Dose 1 (T0) and post dose 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min). SPID24 was include all nominal timepoints from T0 to T24.25 hours. SPID is calculated as Σ\[T(i) -T(i-1)\] x \[(PID(i-1) + PID(i))/2\], where T(0)=0, T(i) is the scheduled time, and PID(i) is the pain intensity difference (PID) score at time i. Pain intensity differences were calculated with respect to Baseline. A baseline assessment is defined as the last non-missing result prior to administration of the first dose of study medication. |
| Primary | Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale. | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours | Pain Relief Rating (PR) was scored on a 5-point scale (0=no-, 1=a little-, 2=some-, 3=a lot of-, and 4=complete- PR). PR was collected at initiation of Dose 1 (T0) and post dose 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours. TOTPAR24 is calculated as Sum (\[T(i) - T(i-1)\] x (PR(i-1) + PR(i)) / 2), where T(0)=0, T(i) is the actual time, and PR(i) is the pain relief score at time i. and calculated as Σ\[T(i) -T(i-1)\] x \[(PR(i-1) + PR(i))/2\], where T(0)=0, T(i) is the scheduled time, and PR(i) is the pain relief (PR) score at time i. |
| Secondary | Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | 0 to 24 Hours | Upon initiation of the infusion of Dose 1, the participants were given stopwatch #1 and asked to press the stopwatch when they first perceived any pain relief (first perceptible pain relief \[FPR\]) ; a record of the time was noted in the participant record. If a participant does not record perceptible pain relief and prematurely discontinued from the study prior to 24 hours, then the participant was censored at time of drop out. If a participant does not record perceptible pain relief prior to taking rescue medication, the participant was censored at 24 hours |
| Secondary | Time to Meaningful Perceptible Relief (MPR) Measure Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | 0 to 24 Hours | Upon initiation of the infusion of Dose 1, the participants were given a second stopwatch and asked to press the stopwatch if and when they feel any meaningful perceptible relief; a record of the time was noted in the participant record. If a participant does not record perceptible pain relief and was prematurely discontinued from the study prior to 24 hours, then the participant was censored at time of drop out. If a participant does not record perceptible pain relief prior to taking rescue medication, the participant was censored at 24 hours. |
| Secondary | Patient Global Evaluation of the Study Medication | 0 to 24 Hours | Patients Global Evaluation was assessed on a scale of 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent) at 24.25 hours post-dose 1 or at participant withdrawal (if applicable), whichever occurred first. Least squares mean of the score are reported. |
| Secondary | Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 hours (± 10 min) | Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to Baseline at each time point after Dose 1 administration. A baseline assessment was defined as the last non-missing result prior to administration of the first dose of study medication |
| Secondary | Pain Intensity Rating at Different Timepoints After Dose 1 Administration | 0 to 24 hours | Pain intensity is reported using the 11-point Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). |
| Secondary | Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration | 0 to 24 hours | Pain Relief is reported on a 5-Point Categorical Pain Relief Assessment scale: 0 = No Pain Relief, 1 = A Little Pain Relief, 2 = Some Pain Relief, 3 = A Lot of Pain Relief, 4 = Complete Pain Relief. |
| Secondary | Time to Treatment Failure | 0 to 24 Hours | Time to treatment failure is defined as time to first dose of rescue medication after Dose 1 or withdrawal from the study for any reason. If a participant does not take rescue medication or withdraw from the study prior to 24 hours, the participant was censored at 24 hours |
| Other | Mean Change From Baseline to 24 Hours in Vital Signs (Systolic Blood Pressure) | 0 to 24 hours | Change from Baseline in systolic blood pressure is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Systolic blood pressure is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale. | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | MEAN |
| SECONDARY | Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | 0 to 24 Hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | hours | MEDIAN |
| SECONDARY | Time to Meaningful Perceptible Relief (MPR) Measure Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | 0 to 24 Hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | hours | MEDIAN |
| SECONDARY | Patient Global Evaluation of the Study Medication | 0 to 24 Hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration | Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 hours (± 10 min) | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | MEAN |
| SECONDARY | Pain Intensity Rating at Different Timepoints After Dose 1 Administration | 0 to 24 hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | MEAN |
| SECONDARY | Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration | 0 to 24 hours | The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | score on a scale | MEAN |
| SECONDARY | Time to Treatment Failure | 0 to 24 Hours | The Evaluable Population included all randomized participant who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1. | hours | MEDIAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to 24 Hours in Vital Signs (Systolic Blood Pressure) | 0 to 24 hours | The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries. | mm Hg | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group248
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale | High Dose APAP | -96.80 | Standard Error 6.369 | score on a scale | |
| Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale | Low Dose APAP | -100.69 | Standard Error 6.333 | score on a scale | |
| Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale | Placebo | -74.96 | Standard Error 9.055 | score on a scale | |
| Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale. | High Dose APAP | 55.82 | Standard Error 3.024 | score on a scale | |
| Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale. | Low Dose APAP | 55.24 | Standard Error 3.007 | score on a scale | |
| Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale. | Placebo | 43.11 | Standard Error 4.300 | score on a scale | |
| Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | High Dose APAP | Median time to FPR-C (hours)- for moderate baseline categorical pain intensity score | 0.215 | Full Range 0.080 to 1.000 | hours |
| Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | Low Dose APAP | Median time to FPR-C (hours)- for moderate baseline categorical pain intensity score | 0.160 | Full Range 0.030 to 0.430 | hours |
| Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | Placebo | Median time to FPR-C (hours)- for moderate baseline categorical pain intensity score | 0.595 | Full Range 0.060 to 24.00 | hours |
| Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups | High Dose APAP | Median time to FPR-C (hours)- for severe baseline categorical pain intensity score | 0.160 | Full Range 0.030 to 24.00 | hours |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Dose APAP | 44 | |
| Overall Study | STARTED | Low Dose APAP | 44 | |
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | COMPLETED | High Dose APAP | 43 | |
| Overall Study | COMPLETED | Low Dose APAP | 44 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | High Dose APAP | 1 | |
| Overall Study | NOT COMPLETED | Low Dose APAP | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | High Dose APAP | 0 | 44 | 0 |
| other | Tachycardia | Cardiac disorders | Low Dose APAP | 1 | 44 | 1 |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 22 | 0 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | High Dose APAP | 0 | 44 | 0 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Low Dose APAP | 1 | 44 | 1 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
| other | Nausea | Gastrointestinal disorders | High Dose APAP | 1 | 44 | 1 |
| other | Nausea | Gastrointestinal disorders | Low Dose APAP | 1 | 44 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 22 | 1 |
| other | Infusion site extravasation | General disorders | High Dose APAP | 1 | 44 | 1 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose APAP | 0 | 44 |
| Total, all-cause mortality | Low Dose APAP | 0 | 44 |
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, other adverse events | High Dose APAP | 9 | 44 |
| Total, other adverse events | Low Dose APAP | 13 | 44 |
| Total, other adverse events | Placebo | 7 | 22 |
| Total, serious adverse events | High Dose APAP | 0 | 44 |
| Total, serious adverse events | Low Dose APAP | 0 | 44 |
| Total, serious adverse events | Placebo | 0 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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