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

Phase 4

Completed

• Conditions: To Control Pain After Third Molar Surgery
• Interventions: Drug: Paracetamol Codeine; Drug: Placebo Oral Tablet

• Registration Number: NCT03049878
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-21
• Primary Completion: 2015-09-20
• Study Completion: 2016-09-10
• Study First Submitted: 2017-01-24
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
analgesic group	Paracetamol Codeine	preoperative oral dose of paracetamol-codeine
placebo group	Placebo Oral Tablet	preoperative placebo (starch)

Primary Outcome Measures

Name	Time	Method
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.	All study participants were asked to record the pain intensity score at 11:00 pm 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")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.	All study participants were asked to record the pain intensity score at 11:00 pm 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")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.	All study participants were asked to record the pain intensity score at 11:00 pm 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")