Injectable Diclofenac for the Prevention of Post-operative Dental Pain

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2013

Interventions

  • Drug: Diclofenac sodium
    • One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.

Arms, Groups and Cohorts

  • Experimental: Diclofenac sodium 5 mg/mL
  • Experimental: Diclofenac sodium 12.5 mg/mL
  • Experimental: Diclofenac sodium 25 mg/mL
  • Experimental: Diclofenac sodium 50 mg/mL
  • Placebo Comparator: Placebo 1 mL

Clinical Trial Outcome Measures

Primary Measures

  • Area Under the Curve (AUC) of the Pain Scores.
    • Time Frame: 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 Measures

  • Postsurgical Extra-oral Swelling
    • Time Frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
  • Trismus
    • Time Frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
  • Peak Pain Intensity
    • Time Frame: measured from end of surgery up to 12 hours postsurgery
  • Time to First Use of Rescue Medication.
    • Time Frame: measured from end of surgery up to 1 week postsurgery
  • Amount of Rescue Medication
    • Time Frame: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
  • Rescue Medication Consumption
    • Time Frame: 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
    • Time Frame: at 6 hour postsurgery and on Day 3
  • Time to Onset of Pain
    • Time Frame: measured from end of surgery up to 12 hours postsurgery
  • Wound Healing
    • Time Frame: at 6 hour postsurgery, and on day 3 and 1 week postsurgery
  • Recurrent Bleeding
    • Time Frame: every hour up to 6 hour postsurgery
  • Vital Signs
    • Time Frame: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
  • Number of Patients With Adverse Events
    • Time Frame: from signature of the informed consent to 1 week postsurgery

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IBSA Institut Biochimique SA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas Dietrich, MD, Principal Investigator, The School of Dentistry, University of Birmingham

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