Effects of Two Packing Type in Maxillofacial Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Sore Throat, Nausea and Vomiting, Postoperative

Intervention / Treatment
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* Drug: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15
* Other: %0.9 NaCl Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHXBNZ<br>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<br>* chlorhexidine gluconate + benzydamine hydrochloride oral rinse<br>|
| Active Comparator: SF<br>Pharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx | Other: %0.9 NaCl Solution<br>* isotonic sodium chloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain. | Postoperatively 2nd hour | 
| Postoperative Pain | Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain. | Postoperatively 4th hour | 
| Postoperative Pain | Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain. | Postoperatively 6th hour | 
| Postoperative Pain | Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain. | Postoperatively 12th hour | 
| Postoperative Pain | Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain. | Postoperatively 24th hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and Vomiting | Measurement with 4 point scale 0 no nausea mild nausea severe nausea vomiting severe and continuously vomiting | Postoperatively 5th minute | 
| Nausea and Vomiting | Measurement with 4 point scale 0 no nausea mild nausea severe nausea vomiting severe and continuously vomiting | Postoperatively 10th minute | 
| Nausea and Vomiting | Measurement with 4 point scale 0 no nausea mild nausea severe nausea vomiting severe and continuously vomiting | Postoperatively 15th minute | 
| Nausea and Vomiting | Measurement with 4 point scale 0 no nausea mild nausea severe nausea vomiting severe and continuously vomiting | Postoperatively 30th minute | 
| Nausea and Vomiting | Measurements with 4 point scale 0 no nausea mild nausea severe nausea vomiting severe and continuously vomiting | Postoperatively 60th minute | 
| Nausea and Vomiting | Measurements with 4 point scale 0 no nausea mild nausea severe nausea vomiting severe and continuously vomiting | Postoperatively 120th minute |