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Trial record 28 of 74 for:    Codeine AND Acetaminophen

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

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ClinicalTrials.gov Identifier: NCT03049878
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Paola Cristalli, 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.


Condition or disease Intervention/treatment Phase
To Control Pain After Third Molar Surgery Drug: Paracetamol Codeine Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, split-mouth, placebo-controlled, double-blind clinical trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 21, 2013
Actual Primary Completion Date : September 20, 2015
Actual Study Completion Date : September 10, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Codeine

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




Primary Outcome Measures :
  1. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. [ Time Frame: All study participants were asked to record the pain intensity score at 1:00 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")

  2. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. [ Time Frame: All study participants were asked to record the pain intensity score at 6:00 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")

  3. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. [ Time Frame: 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")

  4. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. [ Time Frame: All study participants were asked to record the pain intensity score at 8:00 am 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")

  5. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. [ Time Frame: All study participants were asked to record the pain intensity score at 1:00 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")

  6. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. [ Time Frame: All study participants were asked to record the pain intensity score at 6:00 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")

  7. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. [ Time Frame: 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")

  8. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. [ Time Frame: All study participants were asked to record the pain intensity score at 8:00 am 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")

  9. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. [ Time Frame: All study participants were asked to record the pain intensity score at 1:00 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")

  10. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. [ Time Frame: All study participants were asked to record the pain intensity score at 6:00 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")

  11. Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. [ Time Frame: 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")


Other Outcome Measures:
  1. Number of patients using rescue therapy [ 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 ]
    Number of patients using rescue therapy during 3 days after surgery

  2. Time of analgesic medication [ Time Frame: Time elapsed from the end of surgery until the first intake of analgesic medication on the same day of the surgery ]
    Time elapsed from the end of surgery until the first intake of analgesic medication (minutes)

  3. Number of paracetamol-codeine tablets [ Time Frame: Number of paracetamol-codeine tablets taken by the patients during the 3 days after surgery ]
    Total number of paracetamol-codeine tablets with the same formulation taken by the patient in relation to the pain symptoms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049878


Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Maria Paola Cristalli, DDS Sapienza University of Rome

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Paola Cristalli, DDS PhD, Clinical Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03049878     History of Changes
Other Study ID Numbers: 2704/21.02.2013
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Paola Cristalli, University of Roma La Sapienza:
postoperative pain
paracetamol
codeine
tooth extractions
analgesia
premedication
Additional relevant MeSH terms:
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Acetaminophen
Codeine
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents