EVALUATION OF THE EFFECTIVENESS OF PRE-emptive ANALGESIA BY ADMINISTRATION OF PARACETAMOL 500MG + codeine 30mg, FOR THE CONTROL OF POSTOPERATIVE ACUTE PAIN in the extraction of IMPACTED THIRD MOLAR MANDIBULAR

Active, not recruiting

• Conditions: POST-OPERATIVE ACUTE PAIN (DAPO); MedDRA version: 14.1Level: PTClassification code 10031009Term: Oral painSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: PTClassification code 10030973Term: Oral discomfortSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2012-005807-41-IT
• Lead Sponsor: Sapienza University of Rome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-04
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

males and females aged between 18 and 40 years, absence of systemic disease (ASA class I), non-smoking or smoking <10 cigarettes / day; plaque index and bleeding less than 25%, indicating to extract both lower wisdom teeth inclusion in partial or total bilateral bone (osteotomy applicant), similar in depth, inclination and position, no medication in the 10 days prior to the extraction, presence in the arch of the first and second molars, absence of pain and associated osteolytic disease.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

PREGNANT WOMEN AND / OR BREASTFEEDING WOMEN
SUBJECTS < 18 YEARS-OLD

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified