Back to resultsEffects of Two Packing Type in Maxillofacial Surgery
Primary Purpose
Sore Throat, Nausea and Vomiting, Postoperative
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15
%0.9 NaCl Solution
Sponsored by
About this trial
This is an interventional prevention trial for Sore Throat
Eligibility Criteria
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
Sites / Locations
- Ankara University Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHXBNZ
SF
Arm Description
Pharyngeal pack moisturized with chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and placed to oropharynx
Pharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx
Outcomes
Primary Outcome Measures
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Postoperative Pain
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Secondary Outcome Measures
Nausea and Vomiting
Measurement with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Nausea and Vomiting
Measurement with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Nausea and Vomiting
Measurement with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Nausea and Vomiting
Measurement with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Nausea and Vomiting
Measurements with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Nausea and Vomiting
Measurements with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03574246
Brief Title
Effects of Two Packing Type in Maxillofacial Surgery
Official Title
The Effect Of Two Packing Types For Throat Pain And Postoperative Nausea And Vomiting During Maxillofacial Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
December 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat, Nausea and Vomiting, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHXBNZ
Arm Type
Experimental
Arm Description
Pharyngeal pack moisturized with chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and placed to oropharynx
Arm Title
SF
Arm Type
Active Comparator
Arm Description
Pharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx
Intervention Type
Drug
Intervention Name(s)
chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15
Intervention Description
chlorhexidine gluconate + benzydamine hydrochloride oral rinse
Intervention Type
Other
Intervention Name(s)
%0.9 NaCl Solution
Intervention Description
isotonic sodium chloride
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Time Frame
Postoperatively 2nd hour
Title
Postoperative Pain
Description
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Time Frame
Postoperatively 4th hour
Title
Postoperative Pain
Description
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Time Frame
Postoperatively 6th hour
Title
Postoperative Pain
Description
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Time Frame
Postoperatively 12th hour
Title
Postoperative Pain
Description
Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.
Time Frame
Postoperatively 24th hour
Secondary Outcome Measure Information:
Title
Nausea and Vomiting
Description
Measurement with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Time Frame
Postoperatively 5th minute
Title
Nausea and Vomiting
Description
Measurement with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Time Frame
Postoperatively 10th minute
Title
Nausea and Vomiting
Description
Measurement with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Time Frame
Postoperatively 15th minute
Title
Nausea and Vomiting
Description
Measurement with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Time Frame
Postoperatively 30th minute
Title
Nausea and Vomiting
Description
Measurements with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Time Frame
Postoperatively 60th minute
Title
Nausea and Vomiting
Description
Measurements with 4 point scale 0 no nausea
mild nausea
severe nausea
vomiting
severe and continuously vomiting
Time Frame
Postoperatively 120th minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ankara University Faculty of Dentistry
City
Ankara
State/Province
Yenimahalle
ZIP/Postal Code
06560
Country
Turkey
12. IPD Sharing Statement
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Effects of Two Packing Type in Maxillofacial Surgery
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