Postoperative PainNCT06271161
The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting
An observational study of Postoperative Pain and Postoperative Nausea and Vomiting, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting, Throat, Sore
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 2024
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- > 18 year old
- ASA I-II
- Apfel Score<2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the detailed description
The study included 84 ASA I - II patients, over 18 years of age, who would undergo outpatient surgery under general anesthesia in the operating room of Selçuk University Faculty of Dentistry. Apfel score was used to classify patients according to PONV risk. Patients with Apfel scores of 0, 1 and 2 were included in the study. Patients with a history of difficult intubation, patients who could not be intubated at the first attempt, patients with bleeding disorders, motion sickness, malignancy, and patients who had an upper respiratory tract infection in the last 2 weeks were excluded from the study.
The patients were not prescribed any analgesics or anxiolytics before surgery. Pulse oximetry (SpO2), electrocardiogram (ECG), non-invasive blood pressure and end-tidal CO2 pressure (PETCO2) and nasopharyngeal temperature measurement (T), which are standard monitoring methods in general anesthesia applications, were applied to all patients and the values were recorded every 5 minutes. Each patient was administered IV cannulation over the right hand and 1 mg/kg intravenous methylprednisolone and 40 mg pantoprozole were administered before surgery. Anesthesia was induced with 3 mg/kg iv sodium thiopental, 0.6 mg/kg iv rocuronium bromide and 1-1.5 mcg/kg iv fentanyl, and was maintained with 2% sevoflurane in 50% N2O/50% O2. All patients were given appropriate head and neck position before surgery, after nasal intubation with an endotracheal tube (ETT) with lubricating gel applied to the cuff, with the help of a videolaryngoscope. ETT cuff pressure was kept within the range of 20-30 cm H2O with the help of a manometer (VBM, Sultz, Germany) throughout the surgery. The patient's body temperature was monitored by placing a reusable temperature probe into the nasopharynx and recorded during the operation. A throat tampon made of 20x10 cm diameter gauze soaked in saline at +4 ºC was gently placed into the oropharynx by the anesthetist and surgical procedures were initiated.
Demographic data of the patients included in the study such as age, gender, weight, Apfel scores, total doses of opioid drugs used in anesthesia, anesthesia-related data such as ASA score, endotracheal tube diameter, and surgical procedure-related data such as surgical time, surgical procedure, and amount of bleeding were recorded.
During the surgery, the operating room temperature was kept between 22 ºC and 24 ºC. The amount of saline at +4 ºC used to wash the oral cavity during surgical procedures was recorded. At the conclusion of the surgical procedures, the neuromuscular blockade was reversed and the tampon was gently removed by the same anesthesiologist before extubation. All patients were administered IV 50 mg Dexketoprofen just before waking up from general anesthesia.
All patients in the study were extubated and taken to the recovery room. Nausea, vomiting, and sore throat were recorded at the 5th, 10th, and 30th minutes, and at the 1st, 2nd, and 6th hours postoperatively by a surgical assistant who was blinded to the study. IV 20 mg metoclorpamide was used as rescue antiemetic. For pain scores higher than POBA 4, 75 mg tramadol in 100 ml 0.9% saline was administered as a 10-minute IV infusion. Analgesic and antiemetic drug use was recorded as present or absent. All patients were discharged on the day of surgery.
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Pharyngitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
During the surgery, the patient's nasopharyngeal temperature(ºC ), total doses of opioid drugs used (mcg), analgesic and antiemetic drug use (yes/no) in the postoperative recovery room, and the presence/absence of any undesirable events related to the throat pack were recorded.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Nov 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FUNDA ARUN, Selcuk University
- Investigators
- FUNDA ARUN, Ass. Prof., Principal investigator, Selcuk University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271161
- Sponsor's protocol ID
- F002
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting
- ClinicalTrials.gov ID
- NCT06271161
- Acronym / sponsor ID
- F002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The study included 84 ASA I - II patients, over 18 years of age, who would undergo outpatient surgery under general anesthesia in the operating room of Selçuk University Faculty of Dentistry. Apfel score was used to classify patients according to PONV risk. Patients with Apfel scores of 0, 1 and 2 were included in the study. Patients with a history of difficult intubation, patients who could not be intubated at the first attempt, patients with bleeding disorders, motion sickness, malignancy, and patients who had an upper respiratory tract infection in the last 2 weeks were excluded from the study.
The patients were not prescribed any analgesics or anxiolytics before surgery. Pulse oximetry (SpO2), electrocardiogram (ECG), non-invasive blood pressure and end-tidal CO2 pressure (PETCO2) and nasopharyngeal temperature measurement (T), which are standard monitoring methods in general anesthesia applications, were applied to all patients and the values were recorded every 5 minutes. Each patient was administered IV cannulation over the right hand and 1 mg/kg intravenous methylprednisolone and 40 mg pantoprozole were administered before surgery. Anesthesia was induced with 3 mg/kg iv sodium thiopental, 0.6 mg/kg iv rocuronium bromide and 1-1.5 mcg/kg iv fentanyl, and was maintained with 2% sevoflurane in 50% N2O/50% O2. All patients were given appropriate head and neck position before surgery, after nasal intubation with an endotracheal tube (ETT) with lubricating gel applied to the cuff, with the help of a videolaryngoscope. ETT cuff pressure was kept within the range of 20-30 cm H2O with the help of a manometer (VBM, Sultz, Germany) throughout the surgery. The patient's body temperature was monitored by placing a reusable temperature probe into the nasopharynx and recorded during the operation. A throat tampon made of 20x10 cm diameter gauze soaked in saline at +4 ºC was gently placed into the oropharynx by the anesthetist and surgical procedures were initiated.
Demographic data of the patients included in the study such as age, gender, weight, Apfel scores, total doses of opioid drugs used in anesthesia, anesthesia-related data such as ASA score, endotracheal tube diameter, and surgical procedure-related data such as surgical time, surgical procedure, and amount of bleeding were recorded.
During the surgery, the operating room temperature was kept between 22 ºC and 24 ºC. The amount of saline at +4 ºC used to wash the oral cavity during surgical procedures was recorded. At the conclusion of the surgical procedures, the neuromuscular blockade was reversed and the tampon was gently removed by the same anesthesiologist before extubation. All patients were administered IV 50 mg Dexketoprofen just before waking up from general anesthesia.
All patients in the study were extubated and taken to the recovery room. Nausea, vomiting, and sore throat were recorded at the 5th, 10th, and 30th minutes, and at the 1st, 2nd, and 6th hours postoperatively by a surgical assistant who was blinded to the study. IV 20 mg metoclorpamide was used as rescue antiemetic. For pain scores higher than POBA 4, 75 mg tramadol in 100 ml 0.9% saline was administered as a 10-minute IV infusion. Analgesic and antiemetic drug use was recorded as present or absent. All patients were discharged on the day of surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- > 18 year old
- ASA I-II
- Apfel Score<2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 1 month
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 secondary outcome
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.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FUNDA ARUN, Ass. Prof. principal investigator
Selcuk University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Postoperative Nausea and Vomiting, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.