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

To Control Pain After Third Molar Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049878
• Other study ID #: 2704/21.02.2013
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2017
• Last updated: February 7, 2017
• Start date: February 21, 2013
• Est. completion date: September 10, 2016

Study information

• Verified date: February 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 10, 2016
• Est. primary completion date: September 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• To Control Pain After Third Molar Surgery

Intervention

Drug:
• Paracetamol Codeine
preoperative administration
• Placebo Oral Tablet
preoperative administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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