Peritonsillar Abscess
Conditions
Brief summary
The study is a prospective randomized controlled trial conducted at two different centers at the Department of ORL - Head & Neck Surgery, Odense University Hospital and the Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet. The research question is: In a group of patients referred to an otolaryngology department with objective findings of peritonsillar abscess, what are the effects of using intraoral ultrasound to diagnose and guide needle aspiration compared to the traditional landmark-based technique, when measured by the number of performed needle aspirations, procedure-related pain and days on sick leave? The secondary outcomes measured are * Number of hospitalization days * Number of Quincy tonsillectomies * Number of visits to an outpatient clinic * Patient-reported outcome (measured using an 11-point numeric rating scale)
Interventions
DIAGNOSTIC_TESTIntraoral ultrasound
The ultrasound transducer (either Hockey Stick or Burr-Hole N11C5s transducer from BK Ultrasound) is placed on the palatoglossal arch on the affected side and sweeped from the cranial to caudal end of the tonsil to look for an abscess cavity identified as a hypoechoic area with ill-defined margins.
PROCEDUREThe landmark technique
A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.
Sponsors
Odense University Hospital
Tobias Todsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess * Clinical findings of peritonsillar abscess by one of the following: 1. Trismus 2. Unilateral tonsillar/peritonsillar swelling
Exclusion criteria
* Compromised airways or suspected retro / parapharyngeal abscess * Needle aspiration of pus already performed (or participated in the study once earlier) * Cannot understand the written information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| needle aspirations | From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months. | total number of needle aspirations performed |
| proportion of succesfull needle aspirations | From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months. | proportion of needle aspirations with aspiration of pus |
| days on sick leave | From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months. | Total number of days on sick leave after first intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospitalization days | From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months. | — |
| Patient-reported outcome | From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months. | Patients are asked to choose one number, on a scale from 0 (no pain) to 10 (severe pain), corresponding to the intensity of their pain - meassured using a 11-point numeric rating scale (NRS-11). |
| Number of quincy tonsillectomies | From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months. | — |
| Number of visits in outpatient clinic | Until full recovery from peritonsilar infection | — |
Countries
Denmark
Contacts
Primary ContactTobias Todsen, MD, PhD
Outcome results
None listed