Effects of Two Packing Type in Maxillofacial Surgery

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

Study Overview

• Status: Completed
• Conditions: Sore Throat; Nausea and Vomiting, Postoperative
• Intervention / Treatment: Drug: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15; Other: %0.9 NaCl Solution

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 06560
      • Ankara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): December 22, 2018

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Postoperative Complications; Signs and Symptoms, Digestive; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nausea; Vomiting; Postoperative Nausea and Vomiting; Pharyngitis; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Inflammatory Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate; Benzydamine
• Other Study ID Numbers: 36290600/127

Drug and device information, study documents

• 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