The Evaluation of the Effect of Preoperatively Applied Throat Lozenge

The Evaluation of the Effect of Preoperatively Applied Throat Lozenges on Postoperative Sore Throat,Cough and Hoarseness in Patients Operated Under General Anesthesia in Oral and Maxillofacial Surgery Department

Purpose:The aim of this study is to evaluate the effect of preoperative throat lozenge on pain relief in the postoperative period of the mucosal damage caused by intubation in patients who underwent operations in the head and neck region under general anesthesia.

Methods: 60 patients were included in this study who were hospitalized in the inpatient service of the Oral and Maxillofacial Surgery department, This study was single-blind and performed by the same practitioner. Throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).The postoperative sore throat was evaluated by VAS scale (0=no pain, 10=unbearable pain), and cough and hoarseness were evaluated with a four-point Likert scale (0=absent, 3=severe) at 1, 4, 6, 12, and 24 hours.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anesthesia
• Intervention / Treatment: Other: strepsilis; Other: Placebo

Detailed Description

Before the operation, blood sugar, urea, creatinine, electrolytes, prothrombin time, active partial thromboplastin time, and liver enzyme levels were determined in all patients. Hemoglobin and hematocrit determinations were made. Electrocardiography and chest radiographs were taken. Patients whose biochemical tests were within normal limits were included in our study.

The study was single-blind and performed by the same practitioner. Throat lozenge (strepsilis) was given to 30 patients, and sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes). In order not to cause any complications, sugar patients were sucked and told not to chew.

Before the initiation of general anesthesia, height, weight, intubation time, mallampati score and ASA classification, the name of the operation, the start and end time of the operation, smoking, tube number, and whether spasms occurred were recorded. Patients taken to the service in the postoperative period were rested by wearing an oxygen mask. Postoperative sore throat VAS scale (0 = no pain, 10 = unbearable pain), cough, and hoarseness were assessed at 1, 4, 6, 12, and 24 hours with a four-point Likert scale (0 = absent, 3 = severe).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Raha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Being over 18 years old Having ASA I and II scores Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Exclusion Criteria:

Being over 60 years old Complex intubation cases Insulin dependent diabetes Thyroid disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: orthognathic surgery patients / lozange; Throat lozenge (strepsilis) was given to 30 patients,30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).	Other: strepsilis; Throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).
Placebo Comparator: orthognathic surgery patients / candy; Sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation. In order not to cause any complications, sugar patients were sucked and told not to chew.	Other: Placebo; Sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation. In order not to cause any complications, sugar patients were sucked and told not to chew.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperatively applied Throat lozenges on postoperative Sore Throat,Cough and Hoarseness in patients operated under General Anesthesia	postoperatively; sore throat (POST)	1, 4, 6, 12, and 24 hours

Collaborators and Investigators

• Sponsor: Ankara Medipol University
• Investigators: Study Director: mine CAMBAZOĞLU, Prof, Ankara University faculity of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): August 6, 2022

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Orthognathic Surgery; Anesthesia and Analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Ank-Medipol-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No