Effects of Two Packing Type in Maxillofacial Surgery

NCT ID: NCT03574246

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2018-12-22

Brief Summary

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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

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Conditions

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Sore Throat Nausea and Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CHXBNZ

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

chlorhexidine gluconate + benzydamine hydrochloride oral rinse

SF

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

Group Type ACTIVE_COMPARATOR

%0.9 NaCl Solution

Intervention Type OTHER

isotonic sodium chloride

Interventions

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

chlorhexidine gluconate + benzydamine hydrochloride oral rinse

Intervention Type DRUG

%0.9 NaCl Solution

isotonic sodium chloride

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Cagil Vural

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara University Faculty of Dentistry

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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36290600/127

Identifier Type: -

Identifier Source: org_study_id

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