Medical Versus Surgical Treatment for Peritonsillar Abscesses

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority

Criteria

Patient inclusion criteria include:

• 1) Adult patients (> 18 years old),

• 2) Clinical diagnosis of peritonsillar abscess (with or without imaging before consultation).

Patient exclusion criteria include:

• 1) Immunocompromised state, defined as active cancer, present or recent (within 1 year) chemotherapy use, diagnosis or evidence of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) , or diagnosis of an alternative immunodeficiency disorder

• 2) Uncontrolled diabetes mellitus, defined as random blood sugar greater than 12 millimoles per liter,

• 3) Clinical diagnosis of peritonsillar abscess extending to other deep neck spaces, defined as decreased neck range of motion, and clinical gestalt of overall illness,

• 4) Inability to handle secretions as determined by the treating clinician

• 5) Clinically severe dehydration (as determined by treating clinician's volume status assessment) or failure to thrive requiring inpatient admission,

• 6) Requirement of admission for inpatient management for any other reason,

• 7) Requirement of general anesthetic for surgical drainage,

• 8) Unable to consent to study involvement,

• 9) Patient has already received 48 hours of appropriate antibiotic coverage (below) prior to eligibility assessment.

• 10) Previous diagnosis of peritonsillar abscess (other than the current event) within the past month.

Note, the exclusion criteria of inability to handle secretions and severe dehydration are markers of severe disease that likely require surgical intervention. Patient reported dehydration or inability to handle secretions need not exclude potentially eligible patients if the treating clinician determines these factors to be clinically absent or the patient to have mild to moderate infection.

Appropriate antibiotic coverage is defined as:

1. Institutionally standard antibiotics for the treatment of peritonsillar abscess, as determined by the treating physician

2. Any of the following at appropriate dosage range:

1. Amoxicillin-clavulanic

2. Ceftriaxone

3. Clindamycin

4. Penicillin plus metronidazole

5. Cefazolin plus metronidazole