A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries

NCT ID: NCT03678168

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2019-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Post-operative, throat pain, nausea and vomiting is a common occurrence in rhinology surgeries due to the use of throat packs during the procedure. In order to optimize quality of care and patient satisfaction, the aim of this study to evaluate the incidence of post-operative, throat pain, nausea and vomiting in patients that have been packed with either conventional gauze throat packs or pharyngeal tampons.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The nose and para nasal sinuses are anatomically known to be highly vascular and a substantial amount of bleeding is expected from rhinology surgeries, ingested blood is known to be a power full emetic, and the risk aspiration of blood is present due to the fact that an endotracheal tube is not 100% effective in protecting the airway. Post-operative nausea and vomiting is a frequent problem that is encountered in surgical patients with a 4th to 6th fold increase in nasal and endoscopic sinus operations.

Posterior throat pack is an often-used in rhinology surgery, it is said to help in protecting the air way against aspiration and also helps in the reduction of post-operative nausea and vomiting, however many studies concluded that posterior throat pack is associated with higher amount of post-operative pain, nausea,, vomiting and in some rare cases even forgotten in the patient leading to mortality. However, despite poor evidence the placement of posterior throat packs is commonly practiced by surgeons and anesthetists because the possible risk of aspiration is worrisome to the latter and the former.

A conventional throat pack consists of gauze, but an alternative practice involves the pharyngeal placement of tampons. In Marais and Prescott posterior pharyngeal placement of tampons is associated with a decrease amount of post-operative throat pain, when compared to conventional gauze throat packs, however they did not compare the incidence of post-operative nausea and vomiting in both groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Postoperative Pain Bleeding Nose Bleed

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The participants will be unaware of the type of packaging used port rhinology surgery to control pain and bleeding.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Standard care (Throat pack) which will be used as a control.

Group Type OTHER

Throat Pack

Intervention Type OTHER

Post rhinology surgery throat packs will be used as a control to compare against the intervention (Pharyngeal tampons)

Intervention

Pharyngeal tampons which will be used as a comparator against throat pack.

Group Type EXPERIMENTAL

Pharyngeal Tampons

Intervention Type OTHER

Post rhinology surgery Pharyngeal Tampons will be used as an intervention to compare against the throat pack (control)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Throat Pack

Post rhinology surgery throat packs will be used as a control to compare against the intervention (Pharyngeal tampons)

Intervention Type OTHER

Pharyngeal Tampons

Post rhinology surgery Pharyngeal Tampons will be used as an intervention to compare against the throat pack (control)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control Intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults patients ( above the age of 18 years)
* Admitted under Dr. Hiba Al-Reefy
* Underwent a rhinology procedure that required the use of a throat pack

Exclusion Criteria

* Pediatric patients
* Pt who underwent a procedure without the use of throat packs
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Hamad University Hospital, Bahrain

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King Hamad University Hospital

Al Muharraq, Muharraq, Bahrain, Bahrain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bahrain

References

Explore related publications, articles, or registry entries linked to this study.

Piltcher O, Lavinsky M, Lavinsky J, de Oliveira Basso PR. Effectiveness of hypopharyngeal packing during nasal and sinus surgery in the prevention of PONV. Otolaryngol Head Neck Surg. 2007 Oct;137(4):552-4. doi: 10.1016/j.otohns.2007.04.004.

Reference Type BACKGROUND
PMID: 17903569 (View on PubMed)

Fennessy BG, Mannion S, Kinsella JB, O'Sullivan P. The benefits of hypopharyngeal packing in nasal surgery: a pilot study. Ir J Med Sci. 2011 Mar;180(1):181-3. doi: 10.1007/s11845-010-0601-4. Epub 2010 Nov 26.

Reference Type BACKGROUND
PMID: 21110138 (View on PubMed)

Seraj MA, Ankutse MM, Khan FM, Siddiqui N, Ziko AO. Tracheal soiling with blood during intranasal surgery--comparison of two endotracheal tubes. Middle East J Anaesthesiol. 1991 Feb;11(1):79-89.

Reference Type BACKGROUND
PMID: 2067508 (View on PubMed)

Jaiswal V, Bedford GC. Review of the use of throat packs in nasal surgery. J Laryngol Otol. 2009 Jul;123(7):701-4. doi: 10.1017/S0022215109004356. Epub 2009 Feb 4.

Reference Type BACKGROUND
PMID: 19192316 (View on PubMed)

Tay JY, Tan WK, Chen FG, Koh KF, Ho V. Postoperative sore throat after routine oral surgery: influence of the presence of a pharyngeal pack. Br J Oral Maxillofac Surg. 2002 Feb;40(1):60-3. doi: 10.1054/bjom.2001.0753.

Reference Type BACKGROUND
PMID: 11883973 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KHUH/216

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Heated Circuit on Sore Throat
NCT03693417 UNKNOWN NA
Benzydamine Hydrochloride and Post-operative Sore Throat
NCT06676748 NOT_YET_RECRUITING EARLY_PHASE1