Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery
Primary Purpose
To Control Pain After Third Molar Surgery
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Paracetamol Codeine
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for To Control Pain After Third Molar Surgery focused on measuring postoperative pain, paracetamol, codeine, tooth extractions, analgesia, premedication
Eligibility Criteria
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
analgesic group
placebo group
Arm Description
preoperative oral dose of paracetamol-codeine
preoperative placebo (starch)
Outcomes
Primary Outcome Measures
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")
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")
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")
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")
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")
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")
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")
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")
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")
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")
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")
Secondary Outcome Measures
Full Information
NCT ID
NCT03049878
First Posted
January 24, 2017
Last Updated
February 7, 2017
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT03049878
Brief Title
Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 21, 2013 (Actual)
Primary Completion Date
September 20, 2015 (Actual)
Study Completion Date
September 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Control Pain After Third Molar Surgery
Keywords
postoperative pain, paracetamol, codeine, tooth extractions, analgesia, premedication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A randomized, split-mouth, placebo-controlled, double-blind clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
analgesic group
Arm Type
Active Comparator
Arm Description
preoperative oral dose of paracetamol-codeine
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
preoperative placebo (starch)
Intervention Type
Drug
Intervention Name(s)
Paracetamol Codeine
Intervention Description
preoperative administration
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
preoperative administration
Primary Outcome Measure Information:
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 1:00 pm during the operative day
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 6:00 pm during the operative day
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 11:00 pm during the operative day
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery
Title
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Description
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")
Time Frame
All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery
Other Pre-specified Outcome Measures:
Title
Number of patients using rescue therapy
Description
Number of patients using rescue therapy during 3 days after surgery
Time Frame
Number of patients using rescue therapy on the same day from the end of the surgery and during 2 days after operative days
Title
Time of analgesic medication
Description
Time elapsed from the end of surgery until the first intake of analgesic medication (minutes)
Time Frame
Time elapsed from the end of surgery until the first intake of analgesic medication on the same day of the surgery
Title
Number of paracetamol-codeine tablets
Description
Total number of paracetamol-codeine tablets with the same formulation taken by the patient in relation to the pain symptoms
Time Frame
Number of paracetamol-codeine tablets taken by the patients during the 3 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Paola Cristalli, DDS
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28325960
Citation
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.
Results Reference
derived
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Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery
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