Pain Measurement
Conditions
Brief summary
Background and aim: Postoperative pain is an adverse effect of oral surgeries and may therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen and dexamethasone protocols in pain prevention and control after surgical implant placement. Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized clinical trial, 117 dental implants were placed. The groups received three different protocols 1 hour before surgery: 1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose); 2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or 3. placebo. Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate scale, hourly for the first 8 hours after surgery and three times a day on the following 3 days.
Detailed description
This prospective clinical trial investigated the efficacy of preemptive medication in mitigating postoperative pain following dental implant surgeries. With a sample size of 117 participants, the study employed a double-masked, parallel-group, placebo-controlled design. Patients were randomly assigned to receive one of three treatment protocols-an ibuprofen regimen, a dexamethasone regimen, or a placebo-administered one hour before surgery. Pain intensity and discomfort were assessed using numeric, visual, and verbal scales hourly for the first 8 hours post-surgery, followed by thrice-daily evaluations for the next 3 days. Additionally, rescue medication (acetaminophen) was provided to manage pain as needed. The study aimed to determine whether ibuprofen or dexamethasone could effectively alleviate postoperative pain compared to a placebo to highlight optimal pain management strategies for dental implant procedures.
Interventions
DRUGIbuprofen 600 mg
This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
DRUGPlacebo
This group receives 1 hour before surgery placebo.
DRUGAcetaminophen 1000 mg
A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent for the described procedure * Surgical placement of a single endosteal implant * Age of at least 18 years
Exclusion criteria
* The need for bone grafting or sinus lift for implant placement * Pregnant and lactating women * Metabolic disorders * Immunocompromised status * Hemophilia or bleeding disorders * Drug or alcohol abuse * Treatment with steroids in the previous 6 months * History of radiation therapy in the head and neck * Psychiatric disorders * Inability to understand the procedure described in the questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. | 8 hours-time | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain. | 8 hours-time | The 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) |
| The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort. | 8 hours-time | The 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1- Received Ibuprofen (N=39) 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. | 39 |
| Group 2- Received Dexamethasone (N=43) 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. | 43 |
| Group 3 - Received Placebo (N=35) 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. | 35 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 | 6 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 |
Baseline characteristics
| Characteristic | Group 2- Received Dexamethasone (N=43) | Group 3 - Received Placebo (N=35) | Group 1- Received Ibuprofen (N=39) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 35 Participants | 39 Participants | 117 Participants |
| Age, Continuous | 35.0 years | 41.0 years | 33.0 years | 35 years |
| Region of Enrollment Saudi Arabia | 43 participants | 35 participants | 39 participants | 117 participants |
| Sex: Female, Male Female | 23 Participants | 20 Participants | 11 Participants | 54 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 28 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 43 | 0 / 35 |
| other Total, other adverse events | 0 / 39 | 0 / 43 | 0 / 35 |
| serious Total, serious adverse events | 0 / 39 | 0 / 43 | 0 / 35 |
Outcome results
Primary
The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain.
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)
Time frame: 8 hours-time
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1- Received Ibuprofen (N=39) | The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. | 2 score on a scale |
| Group 2- Received Dexamethasone (N=43) | The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. | 2 score on a scale |
| Group 3 - Received Placebo (N=35) | The Visual Analog Scale (VAS) Was Used to Measures Levels of Pain. | 5.0 score on a scale |
Secondary
the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain.
The 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)
Time frame: 8 hours-time
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1- Received Ibuprofen (N=39) | the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain. | 5 score on a scale |
| Group 2- Received Dexamethasone (N=43) | the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain. | 6 score on a scale |
| Group 3 - Received Placebo (N=35) | the 101-point Numerical Rate Scale (NRS-101) Was Used to Measures Levels of Pain. | 39 score on a scale |
Secondary
The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort.
The 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)
Time frame: 8 hours-time
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1- Received Ibuprofen (N=39) | The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort. | 1 score on a scale |
| Group 2- Received Dexamethasone (N=43) | The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort. | 1 score on a scale |
| Group 3 - Received Placebo (N=35) | The 4-point Verbal Rating Scale (VRS-4) Was Used to Measures Levels of Discomfort. | 2 score on a scale |
Comparison: The Kruskal-Wallis test is an omnibus test comparing all three independent groups.p-value: 0.027Kruskal-Wallis
Comparison: The Kruskal-Wallis test is an omnibus test comparing all three independent groups on the pain/discomfort outcome.p-value: <0.0001Kruskal-Wallis