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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03574246

Enrollment

111

Registered

2018-06-29

Start date

2018-01-10

Completion date

2018-12-22

Last updated

2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Postoperative, Sore Throat

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.

Interventions

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

chlorhexidine gluconate + benzydamine hydrochloride oral rinse

OTHER%0.9 NaCl Solution

isotonic sodium chloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative Pain	Postoperatively 2nd hour	Measurements with Visual Analog Scale. Minimum value 0, maximum is 10. 0 is no pain and 10 is intolerable pain.

Secondary

Measure	Time frame	Description
Nausea and Vomiting	Postoperatively 5th minute	Measurement with 4 point scale 0 no nausea 1. mild nausea 2. severe nausea 3. vomiting 4. severe and continuously vomiting

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026