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Completed

NCT Number: NCT03574246

Effects of Two Packing Type in Maxillofacial Surgery

Operations of oral maxillofacial surgery cause the blood escape into stomach and trachea. Therefore, throat packing is applied. Endotracheal tube cuff is not protective from aspiration. While packing is preventing blood leakage, it may cause postoperative pain due to the pressure. Packing placed between oropharynx and hypopharynx before surgery to prevent leakage to stomach and trachea. The aim of this study is to compare the efficacy of two packing types in throat pain.

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Key information

Conditions

Sore Throat Infections Nausea Nausea and Vomiting, Postoperative Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Postoperative Complications Postoperative Nausea and Vomiting Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases Vomiting

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara University Faculty of Dentistry

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who underwent oral maxillofacial surgery (maxillary and mandibular cysts, orthognathic surgery, palate and alveolar clefts, mandibular and maxillary fractures and reconstruction surgeries) under general anesthesia between the ages of 18-60
  • ASA 1-2 groups of patients
  • Patients who have completed growth and development
  • Patients who are willing to comply with the requirements of the study
  • Patients with complete medical records
  • Operations expected to last at least 2 hours

Exclusion criteria

  • Patients with severe systemic disease other than ASA 1-2
  • Difficult entubation story
  • Patients with BMI> 35 kg / m2
  • Contraindications for the use of NSAIDs
  • Patients with diclofenac sodium and metoclopramide allergy
  • Patients whose medical records are inadequate
  • Patients with major tranquilizer or opiate addiction
  • Patients with mental and physical anxiety that would interfere with cooperative operation

Treatment and study plan

chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15

Drug

chlorhexidine gluconate + benzydamine hydrochloride oral rinse

%0.9 NaCl Solution

Other

isotonic sodium chloride

Primary outcomes

  1. Postoperative Pain

    Time frame: Postoperatively 2nd hour

    Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.

  2. Postoperative Pain

    Time frame: Postoperatively 4th hour

    Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.

  3. Postoperative Pain

    Time frame: Postoperatively 6th hour

    Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.

  4. Postoperative Pain

    Time frame: Postoperatively 12th hour

    Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.

  5. Postoperative Pain

    Time frame: Postoperatively 24th hour

    Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.

Secondary outcomes

  1. Nausea and Vomiting

    Time frame: Postoperatively 5th minute

    Measurement with 4 point scale 0 no nausea

    • mild nausea
    • severe nausea
    • vomiting
    • severe and continuously vomiting

  2. Nausea and Vomiting

    Time frame: Postoperatively 10th minute

    Measurement with 4 point scale 0 no nausea

    • mild nausea
    • severe nausea
    • vomiting
    • severe and continuously vomiting

  3. Nausea and Vomiting

    Time frame: Postoperatively 15th minute

    Measurement with 4 point scale 0 no nausea

    • mild nausea
    • severe nausea
    • vomiting
    • severe and continuously vomiting

  4. Nausea and Vomiting

    Time frame: Postoperatively 30th minute

    Measurement with 4 point scale 0 no nausea

    • mild nausea
    • severe nausea
    • vomiting
    • severe and continuously vomiting

  5. Nausea and Vomiting

    Time frame: Postoperatively 60th minute

    Measurements with 4 point scale 0 no nausea

    • mild nausea
    • severe nausea
    • vomiting
    • severe and continuously vomiting

  6. Nausea and Vomiting

    Time frame: Postoperatively 120th minute

    Measurements with 4 point scale 0 no nausea

    • mild nausea
    • severe nausea
    • vomiting
    • severe and continuously vomiting

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

The Effect Of Two Packing Types For Throat Pain And Postoperative Nausea And Vomiting During Maxillofacial Surgery

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2018
Registry last updated
Feb 19, 2019

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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