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Completed

NCT Number: NCT03049878

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

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.

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Key information

Conditions

To Control Pain After Third Molar Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Paracetamol Codeine

Drug

preoperative administration

Placebo oral tablet

Drug

preoperative administration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Feb 10, 2017
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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