- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678168
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Muharraq, Bahrain
-
Muharraq, Muharraq, Bahrain, Bahrain, 244343
- King Hamad University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Control
Standard care (Throat pack) which will be used as a control.
|
Post rhinology surgery throat packs will be used as a control to compare against the intervention (Pharyngeal tampons)
Other Names:
|
EXPERIMENTAL: Intervention
Pharyngeal tampons which will be used as a comparator against throat pack.
|
Post rhinology surgery Pharyngeal Tampons will be used as an intervention to compare against the throat pack (control)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
postoperative throat bleed
Time Frame: 2 years
|
Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative recovery
Time Frame: 2 years
|
Assess the postoperative symptom recovery
|
2 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHUH/216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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