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Completed

NCT Number: NCT03678168

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Hamad University Hospital

Al Muharraq, Muharraq, Bahrain, 244343, Bahrain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Throat Pack

Other

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

Other names: Control

Pharyngeal Tampons

Other

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

Other names: Intervention

Primary outcomes

  1. Comparison of postoperative throat pain using the visual analogue scale (VAS)

    Time frame: 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.

  2. postoperative throat bleed

    Time frame: 2 years

    Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control

Secondary outcomes

  1. Postoperative recovery

    Time frame: 2 years

    Assess the postoperative symptom recovery

Sponsors and collaborators

Lead sponsor

King Hamad University Hospital, Bahrain

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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