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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03678168
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : February 27, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Postoperative Pain Bleeding Nose Bleed Other: Throat Pack Other: Pharyngeal Tampons Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The participants will be unaware of the type of packaging used port rhinology surgery to control pain and bleeding.
Primary Purpose: Treatment
Official Title: A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : September 15, 2019

Arm Intervention/treatment
Standard care (Throat pack) which will be used as a control.
Other: Throat Pack
Post rhinology surgery throat packs will be used as a control to compare against the intervention (Pharyngeal tampons)
Other Name: Control

Experimental: Intervention
Pharyngeal tampons which will be used as a comparator against throat pack.
Other: Pharyngeal Tampons
Post rhinology surgery Pharyngeal Tampons will be used as an intervention to compare against the throat pack (control)
Other Name: Intervention

Primary Outcome Measures :
  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 Outcome Measures :
  1. Postoperative recovery [ Time Frame: 2 years ]
    Assess the postoperative symptom recovery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03678168

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King Hamad University Hospital Recruiting
Muharraq, Muharraq, Bahrain, Bahrain, 244343
Contact: King Hamad U Hospital    1774444   
Principal Investigator: Dr. Hassan Al Ansari, MBBS         
Sponsors and Collaborators
King Hamad University Hospital, Bahrain

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Responsible Party: King Hamad University Hospital, Bahrain Identifier: NCT03678168     History of Changes
Other Study ID Numbers: KHUH/216
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms