Dexketoprofen Trometamol in Postoperative Endodontic Pain

NCT ID: NCT02086097

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-04-30

Brief Summary

The purpose of this study is to investigate the analgesic efficacy of multiple doses of Dexketoprofen Trometamol 25 mg on postoperative pain following emergency endodontic treatment in teeth with irreversible pulpitis, using as control Ibuprofen 600 mg and a placebo group.

Hypothesis:

Dexketoprofen trometamol when administered in multiple doses produces a greater effect to control postoperative pain after treating symptomatic irreversible pulpitis; in patients undergoing pulpotomy as an emergency procedure

Detailed Description

Pain management is an integral part of Endodontics, according to previously published results, pulp therapy and endodontic treatment induce postoperative pain more frequently than other dental procedures.

The prevalence of postoperative pain has been reported in 3-58% of cases, a positive association has been demonstrated between postoperative pain and the presence of apprehension and preoperative pain.

Although the incidence of moderate pain decreases within 1 day and substantially to minimal levels in 7 days after the endodontic treatment, severe postoperative pain occurs during the first 24 h.

Some drugs can prevent the production of inflammatory mediators involved in producing pain, such as prostaglandins.

Prostaglandin tissue levels are associated with patient reports of pain, and therefore, nonsteroidal anti-inflammatory drugs (NSAID's) may be key drugs for inflammatory pain abatement.

NSAIDs are widely available, and they have been reported to be effective in managing endodontic pain.

Ibuprofen is one of the most frequently used NSAIDs for control of postoperative pain associated with root canal treatment, and it has good efficacy and safety.

However an alternative treatment is Dexketoprofen Trometamol, a non-selective nonsteroidal anti-inflammatory drug, and a single isomer (S(+)-enantiomer) of ketoprofen formulated as trometamol salt. Dexketoprofen trometamol has been demonstrated to be effective in the treatment of acute pain.

The purpose of the study is assess the analgesic efficacy of multiple doses of Dexketoprofen Trometamol 25 mg on postoperative pain following emergency endodontic treatment in teeth with irreversible pulpitis This study was designed as a double-blind, randomised, placebo-controlled clinical trial. Following the guidelines suggested by CONSORT group for planning and reporting clinical trials. The ethics committee of the faculty of Dentistry approved the study design. All of the subjects will be informed of the possible risk of endodontic therapy and experimental treatments and will sign institutionally approved consents forms.

In total, 87 patients will be included in this study. The simple size calculation was performed with a type error of 0.05 and statistical power of 80% on the basis of report of the analgesic efficacy of Dexketoprofen Trometamol 25 mg vs Ibuprofen 600 mg after their administration in patients subject to oral surgery.

All of the subjects voluntarily will presented at the postgraduate endodontics clinic of the Faculty of Dentistry at San Luis Potosí University. The select subjects will have a diagnosis of symptomatic irreversible pulpitis.

Pain will be scored using numerical rating scale, this is a 11 point scale where the end points are the extremes of no pain and pain as bad as it could be, or worst pain. Accordingly, no pain corresponded with 0, mild pain with 1-3, moderate pain with 4-6, and severe pain 7 and above.7 After the endodontic emergency treatment, patients will be randomly divided into three groups of 27 patients each. A control group will receive multiple doses of placebo and 2 experimental groups receive multiple dose of ibuprofen (600 mg) and Dexketoprofen trometamol (25 mg). The first dose of medication is given once the procedure is completed, the following doses will be taken every 8 hours to cover a total of 24 hours.

Patients will be monitored to assess the therapeutic effect at different time intervals, 1,8,16,24,48 and 72 hours using numerical rating scale.

If the analgesic efficacy is not achieved Supradol (Ketorolac 30 mg) or Zaldiar (Paracetamol 325mg/Tramadol 37.5 mg) will be taken as rescue medication.Any adverse events or symptoms will be recorded.

Statistics Normal distribution will be tested by the Student's-t test or mann-whitney U test. A non -parametric chi-squared test was performed to identify statistically significant differences between the groups; the level of significance was set at p<0.05.

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

dexketoprofen trometamol

Administration of 25mg of Dexketoprofen Trometamol, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed

Group Type: EXPERIMENTAL

Dexketoprofen trometamol

Intervention Type: DRUG

25m of dexketoprofen (oral intake) every 8 hours

IBUPROFEN

Administration of 600mg of Ibuprofen, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

600 mg of Ibuprofen (Oral Intake) every 8 hours

PLACEBO

4 doses of sugar pills, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

INACTIVE SUGAR PILLS

Interventions

Dexketoprofen trometamol

25m of dexketoprofen (oral intake) every 8 hours

Intervention Type: DRUG

Ibuprofen

600 mg of Ibuprofen (Oral Intake) every 8 hours

Intervention Type: DRUG

PLACEBO

INACTIVE SUGAR PILLS

Intervention Type: DRUG

Other Intervention Names

Miracox (Stein Labs); CODE: 00176101; Ibuprofen Stein; CODE: 00065104; PLAC

Eligibility Criteria

Inclusion Criteria

• Subjects aged 18 years and older with moderate-to-severe dental pain assessed by numerical rating scale (NRS) associated with irreversible pulpitis.

Exclusion Criteria

• • Female pregnant or breastfeeding

• Used pain relievers or anti-inflammatory drugs within 24 hours preceding emergency endodontic treatment
• Have any significant medical condition
• Taking any medications for anxiety, depression or schizophrenia
• Have a history of hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daniel Chavarría Bolaños

OTHER

Sponsor Role: lead

Responsible Party

Daniel Chavarría Bolaños

Basic Sciences Laboratory, Dentistry School

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gisela Rodríguez, DDS

Role: PRINCIPAL_INVESTIGATOR

Universidad Autonoma San Luis Potosi

Amaury J Pozos-Guillen, PhD

Role: STUDY_CHAIR

Universidad Autonoma San Luis Potosi

Daniel Chavarria, PhD

Role: STUDY_DIRECTOR

Universidad Autonoma San Luis Potosi

Locations

Endodontics Master Degree program, Dentistry Faculty, San Luis Potosi University

San Luis Potosí City, San Luis Potosí, Mexico

Countries

Mexico

Other Identifiers

CEIFE-019-013

Identifier Type: -

Identifier Source: org_study_id