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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
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 24, 2017
    Last Updated
    February 7, 2017
    Sponsor
    University of Roma La Sapienza
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    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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