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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

RANDOMIZED CLINICAL TRIAL, PLACEBO-CONTROLLED, SPLIT-MOUTH, A DOUBLE-BLIND, FOR THE 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 - PRE-EMPTIVE ANALGESIA

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005807-41-IT
Enrollment
Unknown
Registered
2013-03-04
Start date
2013-04-28
Completion date
Unknown
Last updated
2013-08-19

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: 14.1 Level: PT Classification code 10031009 Term: Oral pain System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10030973 Term: Oral discomfort System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: COEFFERALGAN Product Name: COEFFERALGAN Pharmaceutical Form: Capsule, hard INN or Proposed INN: CODEINE CAS Number: 52-28-8 Other descriptive name: CODEINE PHOSPHATE Concentration unit: mg

Sponsors

"Sapienza" University of Rome
Lead Sponsor

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

Design outcomes

Primary

MeasureTime frame
Main Objective: The aim of this study was to evaluate the analgesic effect of paracetamol + codeine (P + C) in patients undergoing surgical extraction of mandibular third molars included.;Secondary Objective: - Objective 1: To test the effect of preventive administration of P + C on the intensity of acute post-operative pain (DAPO), also taking into account patient characteristics (age, sex) and surgery (side operated first , duration and degree of difficulty of the operation); - Objective 2: To test the effect of preventive administration of P + C on postoperative consumption of the same drug (measured in number of tablets), also taking into account patient characteristics (age, sex) and surgery (side work first, duration and degree of difficulty of the operation); - Objective 3: To evaluate the effect of time on the variation of the intensity of pain during the post-operative (curve of pain) and the number of analgesic tablets support (rescue therapy) taken by patients; - Objective 4: To assess the effect of rescue therapy on the time variation of the degree of pain. ;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 mm oriented from bottom to top, divided into 11 equal squares with numbers from 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

MeasureTime 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 ContactDEPARTMENT OF ORAL AND MAXILLO FACI

"SAPIENZA" UNIVERSITY OF ROME

susanna.annibali@uniroma1.it00390649976651

Outcome results

None listed

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