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

Primary Purpose

Pain, Postoperative Pain, Bleeding

Status
Completed
Phase
Not Applicable
Locations
Bahrain
Study Type
Interventional
Intervention
Throat Pack
Pharyngeal Tampons
Sponsored by
King Hamad University Hospital, Bahrain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • King Hamad University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Comparison of postoperative throat pain using the visual analogue scale (VAS)
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
Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control

Secondary Outcome Measures

Postoperative recovery
Assess the postoperative symptom recovery

Full Information

First Posted
August 19, 2018
Last Updated
October 21, 2019
Sponsor
King Hamad University Hospital, Bahrain
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1. Study Identification

Unique Protocol Identification Number
NCT03678168
Brief Title
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
Official Title
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Hamad University Hospital, Bahrain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Pain, Bleeding, Nose Bleed

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participants will be unaware of the type of packaging used port rhinology surgery to control pain and bleeding.
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Standard care (Throat pack) which will be used as a control.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Pharyngeal tampons which will be used as a comparator against throat pack.
Intervention Type
Other
Intervention Name(s)
Throat Pack
Other Intervention Name(s)
Control
Intervention Description
Post rhinology surgery throat packs will be used as a control to compare against the intervention (Pharyngeal tampons)
Intervention Type
Other
Intervention Name(s)
Pharyngeal Tampons
Other Intervention Name(s)
Intervention
Intervention Description
Post rhinology surgery Pharyngeal Tampons will be used as an intervention to compare against the throat pack (control)
Primary Outcome Measure Information:
Title
Comparison of postoperative throat pain using the visual analogue scale (VAS)
Description
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.
Time Frame
2 years
Title
postoperative throat bleed
Description
Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Postoperative recovery
Description
Assess the postoperative symptom recovery
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
King Hamad University Hospital
City
Muharraq
State/Province
Muharraq, Bahrain
ZIP/Postal Code
244343
Country
Bahrain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17903569
Citation
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.
Results Reference
background
PubMed Identifier
21110138
Citation
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.
Results Reference
background
PubMed Identifier
2067508
Citation
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.
Results Reference
background
PubMed Identifier
19192316
Citation
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.
Results Reference
background
PubMed Identifier
11883973
Citation
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.
Results Reference
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A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries

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