The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting

NCT06271161 | Completed

• 1 other identifier: F002
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to to evaluate the effects of a throat pack soaked with saline at +4 ºC on postoperative throat pain (POTP) and postoperative nausea and vomiting (PONV) in dental surgical procedures performed under general anesthesia. The main questions it aims to answer are: 1. How long can we keep the pharyngeal mucosa cold using tampons and cold wash solutions? 2. Does cooling the pharyngeal mucosa reduce the incidence of postoperative sore throat and nausea and vomiting?

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting; Throat, Sore; Anesthesia

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative sore throat and noise vomiting was investigated in dental surgery involving the application of cooling to the pharyngeal area, particularly when a throat pack was used.

  The incidence of postoperative throat pain (POTP) was recorded with the following 100 mm VAS scale: 0, no POTP; 1-3, mild POTP (complaining of throat pain only when asked); 4-7, moderate POTP (complaining of throat pain spontaneously); and 8-10, severe POTP (presence of voice change or hoarseness accompanying throat pain). Additionally, the incidence of postoperative nausea and vomiting (PONV) was assessed at the 5th, 10th, and 30th minutes, as well as at the 1st, 2nd, and 6th hours, using the following Myles's simplified PONV impact scale (score \> 0 is regarded as the occurrence of PONV, vomited or dry-retching (0-3 score) and nausea (0-3 score) ,with higher scores indicating being more severe.

  1 month

Secondary Outcomes (1)

• Intraoperative change in nasopharyngeal temperature from baseline (ºC ), intraoperative opioid usage (mcg), postoperative analgesic usage (mg),antiemetic usage(mg) and any adverse events due to throat pack were recorded.

  1 month

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

84 patients who were older than 18 years of age and had ASA (American Society of Anesthesiologists) physical status classification I - II, who underwent outpatient dental surgical procedures under general anesthesia.

You may qualify if:

• \> 18 year old
• ASA I-II
• Apfel Score\<2

You may not qualify if:

• Clinical diagnosis of motion sickness
• Clinical diagnosis of malignancy
• Clinical diagnosis of upper respiratory tract infection in last 2 weeks
• Clinical diagnosis of any bleeding disorders
• Patient that couldn't be intubated at first attempt

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Funda Arun

Selçuklu, Konya, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Pharyngitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• FUNDA ARUN, Ass. Prof.

  Selcuk University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 21, 2024
• Study Start: January 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

TU (1)