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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
The School of Dentistry University of Birmingham
Birmingham, United Kingdom
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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