Medical Versus Surgical Treatment for Peritonsillar Abscesses

NCT04998513 | Withdrawn DMC

• 1 other identifier: 23821
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  The number of eligible patients screened, regardless of participation, will be recorded and compared to the number of participating patients

  1 month

• Retention rates

  The number of patients completing the required follow-ups will be recorded

  1 month

• Compliance

  The number of completed NPS and analgesia diaries will be recorded

  1 month

Secondary Outcomes (1)

• Burden of study involvement of both participants and investigators

  1 month

Other Outcomes (1)

• Future trial outcomes will be examined as per protocol

  1 month

Study Arms (2)

Medical Management Alone Arm

ACTIVE COMPARATOR

Antibiotics, steroids, fluids

Drug: Medical Management Alone Arm

Surgical Arm

ACTIVE COMPARATOR

Incision and drainage

Procedure: Surgical Arm

Interventions

Medical Management Alone Arm DRUG

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.

Medical Management Alone Arm

Surgical Arm PROCEDURE

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.

Surgical Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Adult patients (\> 18 years old),
• \) Clinical diagnosis of peritonsillar abscess (with or without imaging before consultation).

You may not qualify if:

• \) 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
• \) Uncontrolled diabetes mellitus, defined as random blood sugar greater than 12 millimoles per liter,
• \) Clinical diagnosis of peritonsillar abscess extending to other deep neck spaces, defined as decreased neck range of motion, and clinical gestalt of overall illness,
• \) Inability to handle secretions as determined by the treating clinician
• \) Clinically severe dehydration (as determined by treating clinician's volume status assessment) or failure to thrive requiring inpatient admission,
• \) Requirement of admission for inpatient management for any other reason,
• \) Requirement of general anesthetic for surgical drainage,
• \) Unable to consent to study involvement,
• \) Patient has already received 48 hours of appropriate antibiotic coverage (below) prior to eligibility assessment.
• \) Previous diagnosis of peritonsillar abscess (other than the current event) within the past month.
• Appropriate antibiotic coverage is defined as:
• Institutionally standard antibiotics for the treatment of peritonsillar abscess, as determined by the treating physician
• Any of the following at appropriate dosage range:
• Amoxicillin-clavulanic
• Ceftriaxone

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Conditions

Peritonsillar Abscess; Surgical Wound

Condition Hierarchy (Ancestors)

Tonsillitis; Pharyngitis; Respiratory Tract Infections; Infections; Abscess; Suppuration; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Study Officials

• Dr. Matthew H Rigby, MD MPH FRCSC

  Dalhousie University, Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysts will be masked as to the study arm participants are randomized to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed trial is designed as a randomised, controlled, analyst blinded, multi-institutional, pragmatic superiority trial with two parallel groups.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: August 10, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share