A Phase 4 interventional study of DEXKETOPROFEN TROMETAMOL and Placebo in Acute Pain, sponsored by Universidad de Murcia. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-28.
Sponsored by Universidad de Murcia · Phase 4, Interventional, and Prevention
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 100 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Universidad de Murcia is the lead sponsor of 77 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Patients received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery
Drug: DEXKETOPROFEN TROMETAMOL
Patients received a dose of 500 mg Vitamin C in an oral suspension 15 minutes before surgery
Other: Placebo
Patients who were administered a single dose of 25 mg of DKT 15 minutes before surgery
Also known as: Enantyum 25
Patients who were administered a single dose of 500 mg of Vitamin C 15 minutes before surgery
Acute pain after implant surgery
measured by visual analogue scale (VAS) of 100 mm to measure pain intensity
Time frame: 2 years (until complete sample)
Inflammation
Degree of inflammation was measured using a 5-point Likert scale (extremely inflamed, very inflamed, inflamed, somewhat inflamed, and not inflamed).
Time frame: 2 years (until complete sample)
No study locations are listed for this record.
Plan to share: Yes — All data there will be share by personal e-mail
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Universidad de Murcia