Pain
Conditions
Keywords
diclofenac, postsurgical pain, oral surgery
Brief summary
This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.
Interventions
DRUGDiclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Sponsors
IBSA Institut Biochimique SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Out-patients of either gender. 2. Patients aged ≥ 18 to ≤ 65 years old. 3. Subjects able and willing to give their written consent prior to inclusion in the study. 4. Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period. 5. Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study. 6. Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.
Exclusion criteria
General 1. Patients refusing to give written informed consent. 2. Patients not able to understand the purposes of the study or not willing to return for the control visits. 3. Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation. 4. Patients enrolled in any clinical trial in the previous 3 months. 5. Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator. 6. Pregnant or breast-feeding women. 7. Alcohol or drug abuse in the previous 12 months. 8. Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of the Pain Scores. | Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery | Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). |
Secondary
| Measure | Time frame |
|---|---|
| Wound Healing | at 6 hour postsurgery, and on day 3 and 1 week postsurgery |
| Postsurgical Extra-oral Swelling | measured at 6 hours postsurgery, at day 3 and 1 week postsurgery |
| Trismus | measured at 6 hours postsurgery, at day 3 and 1 week postsurgery |
| Peak Pain Intensity | measured from end of surgery up to 12 hours postsurgery |
| Time to First Use of Rescue Medication. | measured from end of surgery up to 1 week postsurgery |
| Recurrent Bleeding | every hour up to 6 hour postsurgery |
| Rescue Medication Consumption | consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery |
| Patient and Investigator Global Evaluation of the Effectiveness of Treatment | at 6 hour postsurgery and on Day 3 |
| Time to Onset of Pain | measured from end of surgery up to 12 hours postsurgery |
| Vital Signs | presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery. |
| Number of Patients With Adverse Events | from signature of the informed consent to 1 week postsurgery |
| Amount of Rescue Medication | consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Sodium 5 mg/mL Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. | 15 |
| Diclofenac Sodium 12.5 mg/mL Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. | 15 |
| Diclofenac Sodium 25 mg/mL Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. | 15 |
| Diclofenac Sodium 50 mg/mL Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. | 14 |
| Placebo 1 mL One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. | 16 |
| Total | 75 |
Baseline characteristics
| Characteristic | Diclofenac Sodium 5 mg/mL | Diclofenac Sodium 12.5 mg/mL | Diclofenac Sodium 25 mg/mL | Diclofenac Sodium 50 mg/mL | Placebo 1 mL | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 7.3 | 28 years STANDARD_DEVIATION 9.4 | 30 years STANDARD_DEVIATION 9 | 27 years STANDARD_DEVIATION 4.5 | 30 years STANDARD_DEVIATION 9.5 | 28.6 years STANDARD_DEVIATION 7.94 |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 12 Participants | 8 Participants | 12 Participants | 47 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 3 Participants | 6 Participants | 4 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 15 | 7 / 15 | 5 / 15 | 5 / 14 | 6 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 16 |
Outcome results
Primary
Area Under the Curve (AUC) of the Pain Scores.
Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
Time frame: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Sodium 5 mg/mL | Area Under the Curve (AUC) of the Pain Scores. | 6843 mm*minutes | Standard Deviation 6259 |
| Diclofenac Sodium 12.5 mg/mL | Area Under the Curve (AUC) of the Pain Scores. | 8832 mm*minutes | Standard Deviation 6330 |
| Diclofenac Sodium 25 mg/mL | Area Under the Curve (AUC) of the Pain Scores. | 9998 mm*minutes | Standard Deviation 8080 |
| Diclofenac Sodium 50 mg/mL | Area Under the Curve (AUC) of the Pain Scores. | 7290 mm*minutes | Standard Deviation 6509 |
| Placebo 1 mL | Area Under the Curve (AUC) of the Pain Scores. | 15539 mm*minutes | Standard Deviation 9279 |
Secondary
Amount of Rescue Medication
Time frame: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
Secondary
Number of Patients With Adverse Events
Time frame: from signature of the informed consent to 1 week postsurgery
Secondary
Patient and Investigator Global Evaluation of the Effectiveness of Treatment
Time frame: at 6 hour postsurgery and on Day 3
Secondary
Peak Pain Intensity
Time frame: measured from end of surgery up to 12 hours postsurgery
Secondary
Postsurgical Extra-oral Swelling
Time frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Secondary
Recurrent Bleeding
Time frame: every hour up to 6 hour postsurgery
Secondary
Rescue Medication Consumption
Time frame: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
Secondary
Time to First Use of Rescue Medication.
Time frame: measured from end of surgery up to 1 week postsurgery
Secondary
Time to Onset of Pain
Time frame: measured from end of surgery up to 12 hours postsurgery
Secondary
Trismus
Time frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Secondary
Vital Signs
Time frame: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
Secondary
Wound Healing
Time frame: at 6 hour postsurgery, and on day 3 and 1 week postsurgery