Medical Versus Surgical Treatment for Peritonsillar Abscesses

Summary

Peritonsillar abscesses are major infections around the tonsils. The abscess is a collection of pus that can cause a large amount of pain and discomfort, which can result in trouble swallowing and drinking. Peritonsillar abscesses must be treated because they can spread to other areas in the throat and neck, which can cause difficulty breathing, can even spread throughout the rest of the body.

Over the years, many different treatments have been used for peritonsillar abscesses. In the past, the entire tonsil was removed in the operating room while the patient was asleep. This surgery can cause a large amount of bleeding, and so now smaller surgeries are performed while the patient is awake. Small needles are put through the open mouth and into the abscess to drain it. As well, a small cut can be made to drain the infection. These last two treatments cause less problems than removing the whole tonsil, but there are still risks. The surgeries are uncomfortable for patients and they can cause anxiety and fear. There are also large blood vessels nearby that can be injured.

In the last few years, treatment of peritonsillar abscesses without surgery has been studied. Patients receive strong antibiotics and anti-inflammatories (known as steroids) and they may not need surgery. It is not yet known if this treatment works as well as surgery. In order to figure this out, research must look at both options compared against each other in a large study with many patients.

However, large research studies require a lot of planning, and so smaller studies are helpful to figure out if the larger study is even possible. The current study would be a small trial to plan for a larger study later on.

Patients will be randomly treated with either medications alone or with surgery. The main part of the study will look at issues with planning the future study, such as how long it takes to fill out forms, how many missing results there are at the end of the study, and how patients and doctors feel about taking part in the research study. The future large study will look at how well the treatment options reduce pain, how fast patients are able to swallow normally again, how often patients need to change treatments, and whether there are differences in quality of life with the treatment options. Because these things will be looked at in detail in the future large study, the investigators will also look at them during this small planning study, but the investigators will not be able to tell for certain which treatment is better until the large study is completed.

The results of this study are important for planning and performing the larger study, and they are important for getting future funding to do that study. Large studies are very expensive, and major funding organizations, such as the Canadian Institutes of Health Research, look for this early data when deciding who should get funding. The results of both this pilot study and the future larger study could be practice changing for how peritonsillar abscesses are treated, and will benefit both Nova Scotians and potentially the rest of world.

Conditions

• Peritonsillar Abscess
• Surgical Incision

Interventions

DRUG

Medical Management Alone Arm

The medical intervention consists of intravenous dexamethasone (10 mg if bodyweight \< 70 kilograms, 20 mg if bodyweight \> 70 kilograms), intravenous cefazolin 2 grams, intravenous metronidazole 500 mg, oral probenecid 2 grams, and 1 liter of intravenous crystalloid fluid given over 1 hour. If, during the initial post-enrolment day 1 follow-up, patients report a failure of signs and symptoms to improve since their medical therapy, a second round of intravenous crystalloid fluid, cefazolin, probenecid, metronidazole and dexamethasone will be given at the same dose as the initial medical therapy. Failure to improve patient signs and symptoms over a two-hour observation window will prompt surgical intervention to be performed in the same fashion as the surgical intervention group.

PROCEDURE

Surgical Arm

Surgical intervention consists of attempted incision and drainage of the abscess. Specific procedure steps and details are at the discretion of the treating surgeon. In general, incision and drainage consists of topical and submucosal local anesthetic followed by a mucosal incision along the palatoglossal arch and soft palate junction, and blunt dissection of the abscess cavity to evacuate pus. Some surgeons may first perform a needle aspiration. For purposes of the trial, positive aspiration of pus on needle aspiration must be followed by attempted incision and drainage. Failed needle aspiration or surgical drainage will be considered as a failed attempt at surgical intervention. Patients randomized to receive surgical intervention will also receive medications as per the medical management arm.

Sponsors & Collaborators

• Nova Scotia Health Authority

  lead OTHER

Principal Investigators

• Dr. Matthew H Rigby, MD MPH FRCSC · Dalhousie University, Nova Scotia Health Authority

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-31

Primary Completion

2022-01-31

Completion

2022-01-31