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

Study Overview
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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.

Official Title
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Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery: a Randomized, Split-mouth, Placebo-controller, Double-blind Clinical Trial

Conditions
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To Control Pain After Third Molar Surgery

Intervention / Treatment
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* Drug: Paracetamol Codeine
* Drug: Placebo Oral Tablet


Participation Criteria
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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. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, split-mouth, placebo-controlled, double-blind clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: analgesic group<br>preoperative oral dose of paracetamol-codeine | Drug: Paracetamol Codeine<br>* preoperative administration<br>|
| Placebo Comparator: placebo group<br>preoperative placebo (starch) | Drug: Placebo Oral Tablet<br>* preoperative administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 1:00 pm during the operative day | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 6:00 pm during the operative day | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 11:00 pm during the operative day | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery | 
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. | The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 (no pain) to 10 (maximum pain) | All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, postoperative pain, paracetamol, codeine, tooth extractions, premedication