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

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

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.

Study Overview

• Status: Completed
• Conditions: To Control Pain After Third Molar Surgery
• Intervention / Treatment: Drug: Paracetamol Codeine; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients using rescue therapy	Number of patients using rescue therapy during 3 days after surgery	Number of patients using rescue therapy on the same day from the end of the surgery and during 2 days after operative days
Time of analgesic medication	Time elapsed from the end of surgery until the first intake of analgesic medication (minutes)	Time elapsed from the end of surgery until the first intake of analgesic medication on the same day of the surgery
Number of paracetamol-codeine tablets	Total number of paracetamol-codeine tablets with the same formulation taken by the patient in relation to the pain symptoms	Number of paracetamol-codeine tablets taken by the patients during the 3 days after surgery

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Maria Paola Cristalli, DDS, University of Roma La Sapienza

Publications and helpful links

General Publications

• Cristalli MP, La Monaca G, De Angelis C, Pranno N, Annibali S. Efficacy of Preoperative Administration of Paracetamol-Codeine on Pain following Impacted Mandibular Third Molar Surgery: A Randomized, Split-Mouth, Placebo-Controlled, Double-Blind Clinical Trial. Pain Res Manag. 2017;2017:9246352. doi: 10.1155/2017/9246352. Epub 2017 Feb 23.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2013
• Primary Completion (Actual): September 20, 2015
• Study Completion (Actual): September 10, 2016

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: analgesia; postoperative pain; paracetamol; premedication; codeine; tooth extractions
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Codeine
• Other Study ID Numbers: 2704/21.02.2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No