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Effects of Two Packing Type in Maxillofacial Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574246
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Cagil Vural, Ankara University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sore Throat Nausea and Vomiting, Postoperative Drug: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 Other: %0.9 NaCl Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect Of Two Packing Types For Throat Pain And Postoperative Nausea And Vomiting During Maxillofacial Surgery
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : December 22, 2018


Arm Intervention/treatment
Experimental: CHXBNZ
Pharyngeal pack moisturized with chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and placed to oropharynx
Drug: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15
chlorhexidine gluconate + benzydamine hydrochloride oral rinse

Active Comparator: SF
Pharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx
Other: %0.9 NaCl Solution
isotonic sodium chloride




Primary Outcome Measures :
  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 Outcome Measures :
  1. Nausea and Vomiting [ Time Frame: Postoperatively 5th minute ]

    Measurement with 4 point scale 0 no nausea

    1. mild nausea
    2. severe nausea
    3. vomiting
    4. severe and continuously vomiting

  2. Nausea and Vomiting [ Time Frame: Postoperatively 10th minute ]

    Measurement with 4 point scale 0 no nausea

    1. mild nausea
    2. severe nausea
    3. vomiting
    4. severe and continuously vomiting

  3. Nausea and Vomiting [ Time Frame: Postoperatively 15th minute ]

    Measurement with 4 point scale 0 no nausea

    1. mild nausea
    2. severe nausea
    3. vomiting
    4. severe and continuously vomiting

  4. Nausea and Vomiting [ Time Frame: Postoperatively 30th minute ]

    Measurement with 4 point scale 0 no nausea

    1. mild nausea
    2. severe nausea
    3. vomiting
    4. severe and continuously vomiting

  5. Nausea and Vomiting [ Time Frame: Postoperatively 60th minute ]

    Measurements with 4 point scale 0 no nausea

    1. mild nausea
    2. severe nausea
    3. vomiting
    4. severe and continuously vomiting

  6. Nausea and Vomiting [ Time Frame: Postoperatively 120th minute ]

    Measurements with 4 point scale 0 no nausea

    1. mild nausea
    2. severe nausea
    3. vomiting
    4. severe and continuously vomiting



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. ASA 1-2 groups of patients
  3. Patients who have completed growth and development
  4. Patients who are willing to comply with the requirements of the study
  5. Patients with complete medical records
  6. Operations expected to last at least 2 hours

Exclusion Criteria:

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

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): NCT03574246


Locations
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Turkey
Ankara University Faculty of Dentistry
Ankara, Yenimahalle, Turkey, 06560
Sponsors and Collaborators
Ankara University

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Responsible Party: Cagil Vural, Specialist, Ankara University
ClinicalTrials.gov Identifier: NCT03574246    
Other Study ID Numbers: 36290600/127
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pharyngitis
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Postoperative Complications
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Benzydamine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Inflammatory Agents