Effects of Two Packing Type in Maxillofacial Surgery

Ankara University

Status and phase: Completed; Phase 4

Conditions: Sore Throat; Nausea and Vomiting, Postoperative

Treatments: Other: %0.9 NaCl Solution; Drug: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15

Study type: Interventional

Funder types: Other

Identifiers

NCT03574246

36290600/127

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups

CHXBNZ

Experimental group

Description:

Pharyngeal pack moisturized with chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15 and placed to oropharynx

Treatment:

Drug: chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15

SF

Active Comparator group

Description:

Pharyngeal pack moisturized with %0,9 NaCl and placed to oropharynx

Treatment:

Other: %0.9 NaCl Solution