Trial Outcomes & Findings for Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement (NCT NCT02763059)
NCT ID: NCT02763059
Last Updated: 2025-11-13
Results Overview
The Visual Analog Scale (VAS) is a 10-cm line with two extremes at either end: "no pain" (0) and "pain that could not be more severe" (10). Patients were asked to mark a point on the line that best represented their perceived level of pain. The marked position on the line was then measured in centimeters to provide a score between 0 and 10. * Minimum Score: 0 (No pain) * Maximum Score: 10 (Pain that could not be more severe) * Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing greater levels of pain. * Unit of Measure: Scores on a scale (0-10)
COMPLETED
PHASE4
132 participants
8 hours-time
2025-11-13
Participant Flow
Participant milestones
| Measure |
Group 1- Received Ibuprofen (N=44)
Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 2- Received Dexamethasone (N=44)
Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 3 - Received Placebo (N=44)
Placebo: This group receives 1 hour before surgery placebo.
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
44
|
|
Overall Study
COMPLETED
|
39
|
43
|
35
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
9
|
Reasons for withdrawal
| Measure |
Group 1- Received Ibuprofen (N=44)
Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 2- Received Dexamethasone (N=44)
Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 3 - Received Placebo (N=44)
Placebo: This group receives 1 hour before surgery placebo.
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
Baseline Characteristics
Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement
Baseline characteristics by cohort
| Measure |
Group 1- Received Ibuprofen (N=39)
n=39 Participants
Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 2- Received Dexamethasone (N=43)
n=43 Participants
Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 3 - Received Placebo (N=35)
n=35 Participants
Placebo: This group receives 1 hour before surgery placebo.
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=10 Participants
|
43 Participants
n=10 Participants
|
35 Participants
n=20 Participants
|
117 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Age, Continuous
|
33.0 years
n=10 Participants
|
35.0 years
n=10 Participants
|
41.0 years
n=20 Participants
|
35 years
n=45 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=10 Participants
|
23 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
54 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=10 Participants
|
20 Participants
n=10 Participants
|
15 Participants
n=20 Participants
|
63 Participants
n=45 Participants
|
|
Region of Enrollment
Saudi Arabia
|
39 participants
n=10 Participants
|
43 participants
n=10 Participants
|
35 participants
n=20 Participants
|
117 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 8 hours-timeThe Visual Analog Scale (VAS) is a 10-cm line with two extremes at either end: "no pain" (0) and "pain that could not be more severe" (10). Patients were asked to mark a point on the line that best represented their perceived level of pain. The marked position on the line was then measured in centimeters to provide a score between 0 and 10. * Minimum Score: 0 (No pain) * Maximum Score: 10 (Pain that could not be more severe) * Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing greater levels of pain. * Unit of Measure: Scores on a scale (0-10)
Outcome measures
| Measure |
Group 1- Received Ibuprofen (N=39)
n=39 Participants
Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 2- Received Dexamethasone (N=43)
n=43 Participants
Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 3 - Received Placebo (N=35)
n=35 Participants
Placebo: This group receives 1 hour before surgery placebo.
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
|---|---|---|---|
|
The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain.
|
2 score on a scale
Interval 1.08 to 4.4
|
2 score on a scale
Interval 1.57 to 3.0
|
5.0 score on a scale
Interval 3.96 to 7.01
|
SECONDARY outcome
Timeframe: 8 hours-timeThe Numerical Rating Scale (NRS-101) is a scale ranging from 0 to 100, where 0 represents "no pain" and 10(0) represents either "the worst possible pain" or "the most intense pain imaginable". * Minimum Score: 0 (No pain) * Maximum Score: 100 (Worst possible pain) * Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived pain. Higher scores indicate worse outcomes, representing higher levels of perceived pain. * Unit of Measure: Scores on a scale (0-100)
Outcome measures
| Measure |
Group 1- Received Ibuprofen (N=39)
n=39 Participants
Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 2- Received Dexamethasone (N=43)
n=43 Participants
Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 3 - Received Placebo (N=35)
n=35 Participants
Placebo: This group receives 1 hour before surgery placebo.
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
|---|---|---|---|
|
the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain.
|
5 score on a scale
Interval 4.74 to 9.19
|
6 score on a scale
Interval 5.66 to 8.37
|
39 score on a scale
Interval 33.65 to 45.06
|
SECONDARY outcome
Timeframe: 8 hours-timeThe 4-point Verbal Rating Scale (VRS-4) is a verbal scale used to assess the severity of a given condition, such as pain. Patients rate their experience by selecting one of four verbal descriptors that best represents their perceived intensity, ranging from "no pain" to "severe pain." * Minimum Score: 0 (No pain) * Maximum Score: 3 (Severe pain) * Interpretation: Lower scores indicate better outcomes, representing lower levels of perceived severity. Higher scores indicate worse outcomes, representing greater levels of severity. * Unit of Measure: Scores on a scale (0-3)
Outcome measures
| Measure |
Group 1- Received Ibuprofen (N=39)
n=39 Participants
Ibuprofen 600 mg: This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 2- Received Dexamethasone (N=43)
n=43 Participants
Dexamethasone 4 mg: This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
Group 3 - Received Placebo (N=35)
n=35 Participants
Placebo: This group receives 1 hour before surgery placebo.
Acetaminophen 1000 mg: A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
|
|---|---|---|---|
|
The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort.
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
2 score on a scale
Interval 1.0 to 3.0
|
Adverse Events
Group 2- Received Dexamethasone (N=43)
Group 3 - Received Placebo (N=35)
Group 1- Received Ibuprofen (N=39)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place