A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
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|ClinicalTrials.gov Identifier: NCT03678168|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Postoperative Pain Bleeding Nose Bleed||Other: Throat Pack Other: Pharyngeal Tampons||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||The participants will be unaware of the type of packaging used port rhinology surgery to control pain and bleeding.|
|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|
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
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
- 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.
- postoperative throat bleed [ Time Frame: 2 years ]Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control
- Postoperative recovery [ Time Frame: 2 years ]Assess the postoperative symptom recovery
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 ClinicalTrials.gov identifier (NCT number): NCT03678168
|King Hamad University Hospital||Recruiting|
|Muharraq, Muharraq, Bahrain, Bahrain, 244343|
|Contact: King Hamad U Hospital 1774444 firstname.lastname@example.org|
|Principal Investigator: Dr. Hassan Al Ansari, MBBS|