How throat packing impacts nasal surgery outcomes: A study on elective procedures
| ISRCTN | ISRCTN12866723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12866723 |
| Secondary identifying numbers | E-15-1696 |
- Submission date
- 18/11/2024
- Registration date
- 20/11/2024
- Last edited
- 20/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study aims to compare different methods of throat packing used during elective nasal surgeries. The goal is to see which method is most effective at reducing post-operative nausea and vomiting (PONV) and post-operative sore throat (POST).
Who can participate?
Patients aged 15-60 years who are undergoing elective nasal surgery under general anesthesia can participate in this study.
What does the study involve?
Participants will be randomly assigned to one of three groups: one group will receive oropharyngeal packing, another will receive nasopharyngeal packing, and the third group will not receive any packing. This packing is done before the surgery begins.
What are the possible benefits and risks of participating?
There are no significant risks, but there is a small chance that the packing could increase nausea, vomiting, or sore throat.
Where is the study run from?
The study is being conducted at King Abdulaziz University Hospital, King Saud University, in Riyadh, Saudi Arabia.
When is the study starting and how long is it expected to run for?
November 2015 to February 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Saad Alsaleh, alssaad@KSU.EDU.SA
Contact information
Public, Scientific, Principal Investigator
King Abdulaziz Rd, Al Malaz
Riyadh
12629
Saudi Arabia
 ORCID ID |
0000-0002-1236-2098 |
|---|---|
| alssaad@KSU.EDU.SA |
Study information
| Study design | Randomized controlled three-arm double-blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Pharyngeal Packing Effects in Elective Nasal Surgeries: a randomized controlled double-blinded trial |
| Study acronym | PENS |
| Study objectives | Pharyngeal packing (oropharyngeal and nasopharyngeal) offers no benefits when compared to no packing in terms of mitigating postoperative nausea and vomiting and postoperative sore throat. |
| Ethics approval(s) |
Approved 26/11/2015, College of Medicine Institutional Review Board (King Saud University, College of Medicine, Riyadh, 11472, Saudi Arabia; +966 11467001; kfaleh@ksu.edu.sa), ref: E-15-1696 |
| Health condition(s) or problem(s) studied | Prevention of postoperative nausea and vomiting and postoperative sore throat in elective nasal surgeries |
| Intervention | Using the sealed envelope method, patients undergoing elective nasal surgeries were randomly allocated to one of three study arms: nasopharyngeal, oropharyngeal, and no packing groups. The first arm will undergo oropharyngeal packing using a moist gauze pack positioned in the oropharynx by the anesthetist. The second arm will undergo nasopharyngeal packing by the operating surgeon, using a Merocel pack inserted into the nasopharynx and a saline injection to seal off the nasopharynx. The third arm will not undergo any packing. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Postoperative nausea and vomiting is measured using the Rhodes nausea and vomiting score at 6 and 24 h postoperatively. 2. Postoperative sore throat pain is measured using a visual analogue scale (VAS) at 6 h, 24 h, and 10 days postoperatively. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/11/2015 |
| Completion date | 28/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 78 |
| Total final enrolment | 99 |
| Key inclusion criteria | 1. 15–60 years 2. Undergoing sinonasal surgery, including septoplasty, unilateral or bilateral functional endoscopic sinus surgery (FESS), inferior turbinoplasty, and open or closed rhinoplasty under general anesthesia (GA). |
| Key exclusion criteria | 1. Patients with documented difficulty in intubation 2. Patients with medical co-morbidities 3. Patients with pre-existing nausea and vomiting |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 28/02/2019 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Riyadh
12629
Saudi Arabia
Sponsor information
University/education
College of Medicine
Riyadh
11472
Saudi Arabia
| Phone | +966 114670011 |
|---|---|
| Kalfaleh@ksu.edu.sa | |
| Website | https://ksu.edu.sa |
"ROR" |
https://ror.org/02f81g417 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal after retrospective registration is completed. |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be available upon request form Leen Alhadlaq (leenalhadlaq@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 20/11/2024 | No | No |
Additional files
Editorial Notes
19/11/2024: Trial's existence confirmed by King Saud University.
