NCT03678168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

August 19, 2018

Last Update Submit

October 21, 2019

Conditions

PainPostoperative PainBleedingNose Bleed

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 years

  • postoperative throat bleed

    Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control

    2 years

Secondary Outcomes (1)

  • Postoperative recovery

    2 years

Study Arms (2)

Control

OTHER

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

Other: Throat Pack

Intervention

EXPERIMENTAL

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

Other: Pharyngeal Tampons

Interventions

Throat PackOTHER

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

Also known as: Control
Control
Pharyngeal TamponsOTHER

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

Also known as: Intervention
Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pediatric patients
  • Pt who underwent a procedure without the use of throat packs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Hamad University Hospital

Al Muharraq, Muharraq, Bahrain, 244343, Bahrain

Location

Related Publications (5)

  • 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.

    PMID: 17903569BACKGROUND

  • 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.

    PMID: 21110138BACKGROUND

  • 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.

    PMID: 2067508BACKGROUND

  • 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.

    PMID: 19192316BACKGROUND

  • 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.

    PMID: 11883973BACKGROUND

MeSH Terms

Conditions

PainPain, PostoperativeHemorrhageEpistaxis

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will be unaware of the type of packaging used port rhinology surgery to control pain and bleeding.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2018

First Posted

September 19, 2018

Study Start

September 5, 2018

Primary Completion

August 15, 2019

Study Completion

September 15, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

BA(1)