Effects of Two Packing Type in Maxillofacial Surgery

Phase 4

Completed

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

• Registration Number: NCT03574246
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-06-29
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SF	%0.9 NaCl Solution	Pharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx
CHXBNZ	chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15	Pharyngeal pack moisturized with chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and placed to oropharynx

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	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

Name	Time	Method
Nausea and Vomiting	Postoperatively 120th minute	Measurements with 4 point scale 0 no nausea; 1. mild nausea; 2. severe nausea; 3. vomiting; 4. severe and continuously vomiting

Trial Locations

Locations (1)

Ankara University Faculty of Dentistry; 🇹🇷 Ankara, Yenimahalle, Turkey