EVALUATION OF THE EFFECTIVENESS OF PRE-emptive ANALGESIA BY ADMINISTRATION OF IBUPROFEN 400MG, FOR THE CONTROL OF POSTOPERATIVE ACUTE PAIN in the extraction of IMPACTED THIRD MOLAR MANDIBULAR

RANDOMIZED CLINICAL TRIAL, PLACEBO-CONTROLLED, SPLIT-MOUTH, A DOUBLE-BLIND, FOR THE EVALUATION OF THE EFFECTIVENESS OF PREemptive ANALGESIA BY ADMINISTRATION OF IBUPROFEN 400MG, FOR THE CONTROL OF POSTOPERATIVE ACUTE PAIN in the extraction of IMPACTED THIRD MOLAR MANDIBULAR - PRE-EMPTIVE ANALGESIA

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003323-11-IT

Enrollment

Registered

2014-02-04

Start date

2014-10-01

Completion date

Unknown

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

POST-OPERATIVE ACUTE PAIN (DAPO) MedDRA version: 17.1 Level: PT Classification code 10031009 Term: Oral pain System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.1 Level: PT Classification code 10030973 Term: Oral discomfort System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: BRUFEN 400 MG Product Name: BRUFEN 400MG Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: males and females aged between 18 and 40 years, absence of systemic disease (ASA class I), non-smoking or smoking =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria will be: persons under age or older than 40 years old; subjects with systemic diseases; Smoking <10 cigarettes / day; plaque index and bleeding than 25%; individuals with anatomical differences between the lower wisdom teeth inclusion in partial or total bilateral bone (osteotomy applicant), with respect to the depth, the 'tilt and position; subjects who took drugs in the 10 days prior to extraction; absence in the arch of the first and second molar; the presence of lytic bone disease and pain symptoms associated with items to be extracted.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study was to evaluate the analgesic effect of ibuprofen in patients undergoing surgical extraction of mandibular third molars included.;Secondary Objective: Objective 1: decrease in the intensity of Acute Post-operative Pain (DAPO) within 3 days after surgery, assessed using a numerical scale (Numeral Rating Scale-11, NRS-11), presented graphically as a vertical column of 100 mm from the bottom-oriented upwards, divided into 11 equal squares with numbers from 0 to 10. Both ends of the scale are defined by "no pain" to "worst pain imaginable." ? Objective 2: postoperative decrease in the consumption of the same drug measured in number of tablets taken within 7 days following surgery.;Primary end point(s): REGISTRATION pain intensity at fixed times (8:00-13:00-18:00-23:00), so as to obtain the "curve of pain"; For the evaluation of the degree of pain, will be used for both diaries a numerical scale (Numeral Rating Scale-11, NRS-11), presented graphically as a vertical column of 100 mmoriented from bottom to top, divided into 11 equal squares with numbersfrom 0 to 10. The two ends of the scale were defined as "no pain" to "worst pain imaginable.";Timepoint(s) of evaluation of this end point: 7 DAYS	—

Measure

Time frame

Main Objective: The aim of this study was to evaluate the analgesic effect of ibuprofen in patients undergoing surgical extraction of mandibular third molars included.;Secondary Objective: Objective 1: decrease in the intensity of Acute Post-operative Pain (DAPO) within 3 days after surgery, assessed using a numerical scale (Numeral Rating Scale-11, NRS-11), presented graphically as a vertical column of 100 mm from the bottom-oriented upwards, divided into 11 equal squares with numbers from 0 to 10. Both ends of the scale are defined by "no pain" to "worst pain imaginable." ? Objective 2: postoperative decrease in the consumption of the same drug measured in number of tablets taken within 7 days following surgery.;Primary end point(s): REGISTRATION pain intensity at fixed times (8:00-13:00-18:00-23:00), so as to obtain the "curve of pain"; For the evaluation of the degree of pain, will be used for both diaries a numerical scale (Numeral Rating Scale-11, NRS-11), presented graphically as a vertical column of 100 mmoriented from bottom to top, divided into 11 equal squares with numbersfrom 0 to 10. The two ends of the scale were defined as "no pain" to "worst pain imaginable.";Timepoint(s) of evaluation of this end point: 7 DAYS

—

Secondary

Measure	Time frame
Secondary end point(s): intake of a possible compressed support (rescue therapy) and the intensity of the pain associated.;Timepoint(s) of evaluation of this end point: 7 DAYS	—

Countries

Italy

Contacts

Public ContactDEPT. OF ORAL AND MAXILLO FACIAL SC

"SAPIENZA" UNIVERSITY OF ROME

susanna.annibali@uniroma1.it00390649976651

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026