Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-21

Study Completion Date

2016-09-10

Brief Summary

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Objectives:

The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar.

Materials and Methods:

The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.

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Detailed Description

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Conditions

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To Control Pain After Third Molar Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, split-mouth, placebo-controlled, double-blind clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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analgesic group

preoperative oral dose of paracetamol-codeine

Group Type ACTIVE_COMPARATOR

Paracetamol Codeine

Intervention Type DRUG

preoperative administration

placebo group

preoperative placebo (starch)

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

preoperative administration

Interventions

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Paracetamol Codeine

preoperative administration

Intervention Type DRUG

Placebo Oral Tablet

preoperative administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* absence of systemic pathologies (ASA class I);
* non-smoker;
* not pregnant or lactating;
* good oral hygiene;
* no drug consumption for 10 days before the operation;
* bilateral impacted mandibular third molars with comparable position, depth and inclination;
* presence of the first and second molars;
* absence of painful symptoms and associated inflammatory or osteolytic pathologies in a radiographic examination;
* extraction difficulty index of \>7 according to Pederson's scale and a degree of IV (complex procedures) on a modified version of Parant's scale.