Injectable Diclofenac for the Prevention of Post-operative Dental Pain

Study Overview
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Brief Summary
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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.

Official Title
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Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery

Conditions
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Pain

Intervention / Treatment
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* Drug: Diclofenac sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-patients of either gender. Patients aged ≥ 18 to ≤ 65 years old. Subjects able and willing to give their written consent prior to inclusion in the study. 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. 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. Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal. Exclusion Criteria: General Patients refusing to give written informed consent. Patients not able to understand the purposes of the study or not willing to return for the control visits. Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation. Patients enrolled in any clinical trial in the previous 3 months. 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. Pregnant or breast-feeding women. Alcohol or drug abuse in the previous 12 months. Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac sodium 5 mg/mL<br> | Drug: Diclofenac sodium<br>* One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.<br>* Other names: Diclofenac HPBCD;|
| Experimental: Diclofenac sodium 12.5 mg/mL<br> | Drug: Diclofenac sodium<br>* One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.<br>* Other names: Diclofenac HPBCD;|
| Experimental: Diclofenac sodium 25 mg/mL<br> | Drug: Diclofenac sodium<br>* One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.<br>* Other names: Diclofenac HPBCD;|
| Experimental: Diclofenac sodium 50 mg/mL<br> | Drug: Diclofenac sodium<br>* One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.<br>* Other names: Diclofenac HPBCD;|
| Placebo Comparator: Placebo 1 mL<br> | Drug: Diclofenac sodium<br>* One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.<br>* Other names: Diclofenac HPBCD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Amount of Rescue Medication |  | consumed by the patient every 15-minutes postsurgery up to 6 hours 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 | 
| Wound Healing |  | at 6 hour postsurgery, and on day 3 and 1 week postsurgery | 
| Recurrent Bleeding |  | every hour up to 6 hour 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diclofenac, postsurgical pain, oral surgery