Effects of Two Packing Type in Maxillofacial Surgery

Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574246
• Other study ID #: 36290600/127
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2018
• Est. completion date: December 22, 2018

Study information

• Verified date: February 2019
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 22, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Postoperative
• Pharyngitis
• Postoperative Nausea and Vomiting
• Sore Throat
• Vomiting

Intervention

Drug:
• chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15
chlorhexidine gluconate + benzydamine hydrochloride oral rinse

Other:
• %0.9 NaCl Solution
isotonic sodium chloride

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Dentistry	Ankara	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Nausea and Vomiting	Measurement with 4 point scale 0 no nausea; mild nausea; severe nausea; vomiting; severe and continuously vomiting	Postoperatively 5th minute
Secondary	Nausea and Vomiting	Measurement with 4 point scale 0 no nausea; mild nausea; severe nausea; vomiting; severe and continuously vomiting	Postoperatively 10th minute
Secondary	Nausea and Vomiting	Measurement with 4 point scale 0 no nausea; mild nausea; severe nausea; vomiting; severe and continuously vomiting	Postoperatively 15th minute
Secondary	Nausea and Vomiting	Measurement with 4 point scale 0 no nausea; mild nausea; severe nausea; vomiting; severe and continuously vomiting	Postoperatively 30th minute
Secondary	Nausea and Vomiting	Measurements with 4 point scale 0 no nausea; mild nausea; severe nausea; vomiting; severe and continuously vomiting	Postoperatively 60th minute
Secondary	Nausea and Vomiting	Measurements with 4 point scale 0 no nausea; mild nausea; severe nausea; vomiting; severe and continuously vomiting	Postoperatively 120th minute