NCT03574246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2018

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

May 24, 2018

Last Update Submit

February 18, 2019

Conditions

Sore ThroatNausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • Nausea and Vomiting

    Postoperatively 5th minute

  • Nausea and Vomiting

    Postoperatively 10th minute

  • Nausea and Vomiting

    Postoperatively 15th minute

  • Nausea and Vomiting

    Postoperatively 30th minute

  • Nausea and Vomiting

    Postoperatively 60th minute

  • +1 more secondary outcomes

Study Arms (2)

CHXBNZ

EXPERIMENTAL

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

SF

ACTIVE COMPARATOR

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

Other: %0.9 NaCl Solution

Interventions

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

chlorhexidine gluconate + benzydamine hydrochloride oral rinse

CHXBNZ
%0.9 NaCl SolutionOTHER

isotonic sodium chloride

SF

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • ASA 1-2 groups of patients
  • Patients who have completed growth and development
  • Patients who are willing to comply with the requirements of the study
  • Patients with complete medical records
  • Operations expected to last at least 2 hours

You may not qualify if:

  • Patients with severe systemic disease other than ASA 1-2
  • Difficult entubation story
  • Patients with BMI\> 35 kg / m2
  • Contraindications for the use of NSAIDs
  • Patients with diclofenac sodium and metoclopramide allergy
  • Patients whose medical records are inadequate
  • Patients with major tranquilizer or opiate addiction
  • Patients with mental and physical anxiety that would interfere with cooperative operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PharyngitisPostoperative Nausea and Vomiting

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 29, 2018

Study Start

January 10, 2018

Primary Completion

December 15, 2018

Study Completion

December 22, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

TU(1)