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

Not Applicable

Completed

• Conditions: Pain; Postoperative Pain; Bleeding; Nose Bleed
• Interventions: Other: Pharyngeal Tampons; Other: Throat Pack

• Registration Number: NCT03678168
• Lead Sponsor: King Hamad University Hospital, Bahrain

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-08-19
• Study Start: 2018-09-05
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Primary Completion: 2019-08-15
• Study Completion: 2019-09-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pharyngeal Tampons	Pharyngeal tampons which will be used as a comparator against throat pack.
Control	Throat Pack	Standard care (Throat pack) which will be used as a control.

Primary Outcome Measures

Name	Time	Method
Comparison of postoperative throat pain using the visual analogue scale (VAS)	2 years	Evaluation of postoperative pain between pharyngeal tampons and controls using the Visual Analogue scale. A value of 0 is the lowest value and indicates the patient is pain free. And a score of 10 is the maximum value which indicates extreme pain on the scale.
postoperative throat bleed	2 years	Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control

Secondary Outcome Measures

Name	Time	Method
Postoperative recovery	2 years	Assess the postoperative symptom recovery

Trial Locations

Locations (1)

King Hamad University Hospital; 🇧🇭 Muharraq, Muharraq, Bahrain, Bahrain