Peritonsillar abscess Infections and Infestations Peritonsillar abscess
Conditions
Interventions
Participants are randomly allocated to one of two groups using consecutively numbered envelopes including the decision for the treatment strategy.
Group 1: Participants receive the incision and drain
Sponsors
University Medical Center Göttingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years 2. Peritonsillar abscess 3. Informed consent
Exclusion criteria
Exclusion criteria: 1. Absence of informed consent 2. Secondary diagnosis that require regular analgetic medication 3. Psychiatric disorders (e.g. somatization disorder and affective disorders) 4. Pregnancy and breastfeeding 5. Chronic renal and liver disease 6. Gastric ulcer 7. Bone marrow diseases and diseases of the haematopoetic system 8. Medication of acetylsalicylic acid, coumarin derivatives or other anticoagulant medication in the last 10 days 9. Severe secondary diagnosis that go along with increased risk for general anesthesia 10. Limited cooperation or trismus severity that make Incision and drainage in local anesthesia impossible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain is measured using the numeric rating scale (pain in rest, pain during swallowing) and the visual analogue scale (pain relief by intervention) at baseline before intervention (pain in rest, pain during swallowing) and directly after intervention (pain in rest, pain during swallowing and pain relief by intervention). Afterwards at the day of intervention the two questions to measure pain (pain in rest, pain during swallowing) are asked every 2 hours as well as 30 minutes before and 60 minutes after taking pain medication. From the first day after intervention on, the two questions are asked every 3 hours as well as before and after taking pain medication, and at 1 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction is measured using the visual analogue scale (VAS) directly after intervention, at first day after intervention and before discharge 2. Required pain medication is measured by reviewing the records of the nursing team that regularly documents analgetics given to the patients 3. Trismus is measured using a metric tape measure at baseline before intervention and every day after during the hospital stay 4. Temperature is measured using a medical thermometer at baseline before intervention and every day after during the hospital stay 5. Inflammation is measured by white blood cells (WBC) and C-reactive protein (CRP) laboratory tests at baseline before intervention, at the second day after intervention and before discharge 6. Rate on pus drainage, required number of punctures and incisions, residual abscesses is measured during intervention and during follow up at hospital stay if re-interventions would be necessary 7. Complication rate is measured by documentation of all specific incidents occurring during hospital stay. When patients are seen for follow up at 1 and 6 month they are asked for the occurrence of special incidents 8. Specific (TOI-14) and general (15D) health related quality of life are measured using the Tonsillectomy Outcome Inventory 14 and the 15D-questionaire. The TOI-14 questionnaire is given to the patient at baseline and at 6 month follow up visit. The 15D questionnaire is given to the patient at baseline, the day after intervention, before discharge and at 1 and 6 month follow up visit. 9. Patient's benefit from otorhinolaryngological surgery and therapy is measured using the Glasgow Benefit Inventory at the 1 month follow up visit 10. Length of hospital stay is measured by prospective documentation 11. Time to full recovery and to resume work is measured using a response letter that is handed to the patient at discharge from hospital 12. Rate of recurrent tonsillitis, peritonsillar abscesses or two-stage tonsillectomy is m | — |
Countries
Germany
Outcome results
None listed