NCT02380001

Brief Summary

The purpose of the present investigation is to evaluate the effectiveness of the preoperative administration of Dexketoprofen Trometamol, employing the third molar surgery model, when compared to postoperative administration of the same drug. It was hypothesized that preoperative oral Dexketoprofen trometamol will reduce the intensity of pain by 30% after 8 hours of the surgery, when compared with post-operative administration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

February 22, 2015

Last Update Submit

August 12, 2015

Conditions

Postoperative Pain

Keywords

Postoperative painDexketoprofen trometamolthird molar surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS).

    Postoperative pain measurement will be held every 8 hours for the next 72 hours after the surgical intervention

    72 hours

Secondary Outcomes (2)

  • Number of patients with adverse events, to determine tolerability of the drugs.

    7 days

  • needing of second dosage administration

    72 hours

Study Arms (2)

Dexketoprofen trometamol

EXPERIMENTAL

A White round pill with 25 mg of dexketoprofen will be administered 30 minutes before the impacted third molar surgery start. Immediately after the surgery, a hard-gelatin capsule with placebo will be administered.

Drug: Dexketoprofen trometamol

Preoperative control

PLACEBO COMPARATOR

A hard-gelatin capsule with placebo will be administered 30 minutes before the impacted third molar surgery start. Immediately after the surgery, a hard-gelatin capsule with 25mg of Dexketoprofen will be administered.

Drug: Preoperative control

Interventions

Dexketoprofen trometamolDRUG

White round pill containing 25mg of Dexketoprofen will be administered either prior/after to third molar surgery.

Also known as: Enantyum, Miracox
Dexketoprofen trometamol
Preoperative controlDRUG

white round pill containing 25mg of placebo will be administered prior/after to third molar surgery. The placebo pill is identical to active dexketoprofen, in size and color

Also known as: Placebo
Preoperative control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers between 18-28 years old
  • Clinical and radiographic diagnosis of impacted mandibular third molars, which the surgical approach may include flap and osteotomy procedures.
  • surgery classified as simple to moderate
  • Voluntary acceptance of written consent, previously approved by institutional ethics committee

You may not qualify if:

  • Prior administration of analgesic or anti-inflammatory drugs
  • History of drug dependence
  • History of allergic reactions to any of the drugs selected, or local anesthetics
  • Simultaneous presence of oral pathologies that may interfere with the surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FACULTY OF MEDICINE, San Luis Potosi University

San Luis Potosí City, San Luis Potosí, 78290, Mexico

Location

Related Publications (36)

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    PMID: 1947892BACKGROUND

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    PMID: 8922555BACKGROUND

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  • Cagiran E, Eyigor C, Sezer B, Uyar M. Preemptive analgesic efficacy of dexketoprofen trometamol on impacted third molar surgery. Agri. 2014;26(1):29-33. doi: 10.5505/agri.2014.55265.

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  • Esparza-Villalpando V, Chavarria-Bolanos D, Gordillo-Moscoso A, Masuoka-Ito D, Martinez-Rider R, Isiordia-Espinoza M, Pozos-Guillen A. Comparison of the analgesic efficacy of preoperative/postoperative oral dexketoprofen trometamol in third molar surgery: A randomized clinical trial. J Craniomaxillofac Surg. 2016 Sep;44(9):1350-5. doi: 10.1016/j.jcms.2016.06.002. Epub 2016 Jun 9.

    PMID: 27378000DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Amaury Pozos, PhD

    Universidad Autonoma de San Luis Potosí

    STUDY DIRECTOR

  • Vicente Esparza, Resident

    Universidad Autonoma de San Luis Potosí

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Daniel Chavarría Bolaños, MSc. PhD

Study Record Dates

First Submitted

February 22, 2015

First Posted

March 5, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations

ME(1)