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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 August 2015 |
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Main ID: |
NCT02380001 |
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Date of registration:
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22/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Analgesic Preoperative/Postoperative Dexketoprofen Trometamol in Third Molar Surgery
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Scientific title:
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Analgesic Efficacy of Preoperative Oral Administration of Dexketoprofen Trometamol in Third Molar Surgery, Compared to Postoperative Administration |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02380001 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Amaury Pozos, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Autónoma de San Luis Potosí |
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Name:
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Vicente Esparza, Resident |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Autónoma de San Luis Potosí |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Drug: Dexketoprofen trometamol
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Drug: Preoperative control
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Primary Outcome(s)
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Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS).
[Time Frame: 72 hours]
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Secondary Outcome(s)
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needing of second dosage administration
[Time Frame: 72 hours]
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Number of patients with adverse events, to determine tolerability of the drugs.
[Time Frame: 7 days]
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Secondary ID(s)
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CEI-FE-028-014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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