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

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: To Control Pain After Third Molar Surgery

Treatments: Drug: Placebo Oral Tablet; Drug: Paracetamol Codeine

Study type: Interventional

Funder types: Other

Identifiers

NCT03049878

2704/21.02.2013

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

analgesic group

Active Comparator group

Description:

preoperative oral dose of paracetamol-codeine

Treatment:

Drug: Paracetamol Codeine

placebo group

Placebo Comparator group

Description:

preoperative placebo (starch)

Treatment:

Drug: Placebo Oral Tablet