post-surgical pain after lower third molar removal. MedDRA version: 15.0 Level: LLT Classification code 10036286 Term: Post-operative pain System Organ Class: 100000004863
Conditions
Sponsors
IBSA Institut Biochimique S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Patients 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 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. Trial specific 9. Contralateral lower 3rd molar extraction or any other concomitant extraction. 10. Surgery requiring general anaesthesia or sedation (including nitrous oxide by inhalation). 11. Acute local or systemic infection occurring before surgery that in the investigator’s opinion, could confound the post-surgical evaluation. 12. Patients with clinical signs or history of gastrointestinal disorders (e.g. gastritis, gastro-duodenal ulcer, gastrointestinal bleeding). 13. Clinical signs or history of coagulation disorders. 14. Patients with significant cardiac impairment (e.g. heart failure, ischemic heart disease), history of cerebrovascular disease (e.g. ictus), history of peripheral arterial disease or uncontrolled hypertension, (i.e. not stable = repeated measurements of systolic pressure > 160 mmHg or diastolic pressure > 95 mmHg, despite pharmacological treatment). 15. Hepatic or renal impairment. 16. Hypersensitivity to diclofenac or other NSAIDs. 17. Patients under chronic treatment with topical or systemic analgesics/NSAIDs. 18. Patients who have taken any medication as reported below: Non-Permitted Medications and wash-out period before surgery: Systemic NSAIDs or analgesics 24 hours Major or minor tranquilizers* 24 hours Muscle relaxers 24 hours Antihistaminesº 24 hours Long-acting NSAIDs 7 days Opioids 7 days MAO inhibitors 2 weeks Other antidepressants: SSRI, serotonin/norepinephrine reuptake inhibitors, and tricyclics 3 weeks Corticosteroids (any route of administration)2 months *Benzodiazepine-type anxiolytics with analgesic or muscle relaxant effect are allowed if their use had been started at least 6 months earlier for other medical reasons (their dose must be maintained unchanged during the study). ºUnless their use had been started at least 6 months earlier for other medical reasons (their dose must be maintained unchanged during the study). 19. Patients under treatment with any medication that may interact with diclofenac: lithium, digoxin, diuretics, corticosteroids and other NSAIDs, anticoagulants and anti-platelet agents, antidiabetics, methotrexate, cyclosporine, quinolone antimicrobials, phenytoin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will evaluate the analgesic efficacy and local tolerability of single doses of diclofenac sodium at four different strengths 5, 12.5, 25 and 50 mg/mL injected directly at the surgical area prior to oral surgery.;Secondary Objective: ;Primary end point(s): The primary efficacy variable of the study will be the Area Under the Curve (AUC) of the pain scores over the time from end of surgery (time 0) to the 6 hour post-surgery. Pain will be scored by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).;Timepoint(s) of evaluation of this end point: Pain assessed by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Timepoints of evaluation of each secondary endpoint are described in the section above.;Secondary end point(s): • Pain assessed by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours using a 100 mm VAS. After the in-clinic observation period, pain will be assessed hourly for an additional 6 hours and recorded in the patient diary. Pain will be also assessed at first rescue medication consumption. • Time to onset of pain. Starting time will be defined as the time at which surgery was completed to the first report of clinically meaningful pain (i.e. pain of 30 mm on the VAS scale). • Postsurgical extra-oral swelling will be also assessed measuring the distance between tragus and chin by the investigator immediately before administration of local anaesthesia, at 6h postoperatively before discharge, and at visits 2 and 3 • Trismus (defined as distance between the left upper and lower incisors at maximal opening) will be measured by the investigator immediately before administration of local anaesthesia, at 6 hours postoperatively before discharge, and at visits 2 and 3. • Peak pain intensity will be the highest pain intensity observed during the 12 hours observation period. • Time to first use of rescue medication. • Amount of rescue medication (number of paracetamol tablets) used in each 15-minute time period. • Rescue medication consumption over the 24- and 48-hour intervals as described in the patient diary. • Patient and investigator global evaluation of the effectiveness of treatment, assessed after the 6 hour observation period and on Day 3 using a 5-point scale, where 4 = excellent; 3 = good; 2 = fair; 1 = poor; 0 = ineffective. Safety Variables: • Assessment of adverse events at any time during the study, particularly any local reaction(s) not commonly observed in the postsurgical period. • Assessment of wound healing by evaluating the severity of common (i | — |
Countries
United Kingdom
Contacts
Public ContactBarbara Gugliotta
IBSA Institut Biochimique S.A.
Outcome results
None listed