Acute Pain Clinical Trial
Official title:
Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: a Randomized, Double-blind Controlled Trial.
The objective of this prospective randomized double-blind study was to evaluate the effects
of the preoperative administration of dexketoprofen trometamol (DKT) on the pain perceived by
patients after oral surgery for implant placement.
Materials and Method: Single oral doses of 25 mg DKT or PLACEBO were administered 15 minutes
before the performance of conventional implant surgery to assess the influence of the DKT on
pain as reported by the patients. One hundred patients who required single-implant treatments
were randomly distributed into one of the two blinded groups following a preliminary
examination. Fifteen minutes before surgery, the patients in the test group were given 25 mg
DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo
(PLACEBO group). The patients' pain intensities were measured using a subjective visual
analogue scale of 100 mm in length, and pain was measured over a period of 7 days.
Inflammation was assessed using a 5-point Likert scale on days 2 and 7.
A total of 100 consecutive patients (November 2013 to October 2015) scheduled for implant
surgery in the University Dental Clinic (Murcia, Spain) were included in this study. All
patients were older than 18 and were free of medical and surgical contraindications and
systemic disease that would conflict with treatment (American Society of Anesthesiologists
(ASA) risk I or II). All participants in the study were able to read, understand and respond
to the health questionnaire and were able to sign an informed consent document. This study
was performed in accordance with the 2014 revision of the Declaration of Helsinki (General
Assembly of the World Medical Association, 2014).
Clinical materials The study protocol was approved by the Ethics Committee of the University
of Murcia.
The study was conducted with a double blind randomized design using a visual analogue scale
(VAS) of 100 mm to measure pain intensity. The degree of inflammation was measured using a
5-point Likert scale (extremely inflamed, very inflamed, inflamed, somewhat inflamed, and not
inflamed).
Patients signed two informed consent forms, one for the implant surgery, and the other for
participation in the study; the latter explicitly mentioned the patients' ability to leave
the study at any time.
A local anaesthetic composed of lidocaine hydrochloride and epinephrine (20 mg/ml + 0.0125
mg/ml, respectively) was applied (never alveolar nerve block).
All implants had sandblasted and acid-etched surfaces (TiCare Inhex®, Mozo Grau / Ticare,
Valladolid, Spain). All implants were placed by the same surgeon (ASP) following the
recommendations of the manufacturer (total = 100 implants).
The test group received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery,
and the control group received 500 mg vitamin C 15 minutes before surgery. Both solutions
were administered in an orange disposable cup to mask the small difference in colour.
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