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Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use

Postoperative Healthcare Utilization in Adenotonsillectomy Patients With Postoperative Antibiotic Administration Compared to Patients Without Antibiotic Administration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01561703
Enrollment
58
Registered
2012-03-23
Start date
2012-03-31
Completion date
2015-06-30
Last updated
2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Snoring, Strep Throat

Keywords

Healthcare utilization, Tonsillectomy, Adenoidectomy/Tonsillectomy, Antibiotics

Brief summary

This study is designed to look at healthcare utilization following the removal of tonsils and adenoids in pediatric patients who are not given an antibiotic following surgery.

Detailed description

The objective for this trial is to provide evidence that not prescribing postoperative antibiotics increases the number of phone calls to the physician, increases the number of emergency department/urgent care/clinic visits in the postoperative period, and increases medical diagnostic costs (ie: labwork, cultures, x-rays). Additionally, the investigators aim to provide evidence that a higher percentage of patients not given a prescription for antibiotics will ultimately obtain a prescription from another provider. One of the most common surgical procedures performed in the pediatric population is tonsillectomy. The term tonsillectomy refers to the surgical excision of the entire tonsil tissue and may or may not include excision of the adenoid tissue as well. Typical symptoms following surgery are pain, malaise, and fever among others. Otolaryngologists for many years have prescribed antibiotics postoperatively based on early randomized controlled trials that suggested a benefit in improved recovery. A recent poll showed that 79% of otolaryngologists routinely prescribe antibiotics to reduce postoperative morbidity and not for antibiotic prophylaxis. The American Academy of Otolaryngology-Head and Neck Surgery (AAOHNSF) recently published an evidenced-based Clinical Practice Guideline for tonsillectomy in children in which the routine use of postoperative antibiotics was evaluated. Evaluation of more recent literature showed that routine use of post-operative antibiotics does not show benefit in improving the main measures of perioperative morbidity . Multiple individual trials showed that antibiotic use had no impact on pain, amount of analgesic use, recovery time, or time required to return to a normal diet. However, routine antibiotic use for prevention of postoperative fever remains in controversy and has shown benefit in two trials and while showing no benefit in two different trials. Considering the lack of supporting evidence of benefit in reducing postoperative morbidity, the AAOHNSF has issued a strong recommendation against the routine administration of postoperative antibiotics for tonsillectomy. The investigators experience as a very busy pediatric surgical service is that in the 1-2 weeks following tonsillectomy, physicians and clinics commonly receive phone calls from concerned parents regarding local and referred pain, bad breath, and fever. Despite patient education at several steps during the process, parental phone calls regarding postoperative fever remain common. While post-operative fever is known to occur following tonsillectomy, management of this issue on the phone, sometimes over the weekend, can be challenging. Children are often in pain, more tired than usual, and not eating well. Even though these are all anticipated symptoms, when they occur with fever, it is difficult to provide adequate reassurance to a concerned parent. Often parents think their child has an infection and are expecting that their provider will start an antibiotic. From the clinician perspective, it can be difficult to discern whether or not there is a concurrent illness that should be evaluated. As a result, parents often bring their children to an urgent care clinic, emergency department, or physician clinic for evaluation and may eventually obtain an antibiotic prescription for their complaints to cover a possible infection. While routine use of antibiotics does not show benefit in improving many of the main elements of morbidity, controversy remains regarding reduction of postoperative fever. When a fever occurs in a child who is not taking an antibiotic, parents often become concerned about an infection and desire an antibiotic and further evaluation. The concern of the parent in some cases leads to unnecessary visits to emergency departments, urgent care clinics, and physician clinics for evaluation. The workup performed in the evaluation of these patients may include complete blood count, chest x-ray, urinalysis, and urine cultures. Ultimately, the patient may be given an empiric antibiotic prescription. To date there has been no literature documenting healthcare utilization compared between patients who were given antibiotics and those who were not given antibiotics. The goal of this study is to evaluate healthcare utilization and patient/caregiver burden between these groups. If increased healthcare utilization and patient/caregiver burden is found in the no antibiotic group, then analysis of the type of utilization and outcome will direct future efforts to improve patient education regarding postoperative morbidity or possibly to continue routinely administering post operative empiric antibiotics. This will benefit in the effort to improve patient satisfaction with surgery, reduce unnecessary healthcare costs, and reduce unnecessary antibiotic use.

Interventions

DRUGAntibiotic

One of seven antibiotics (amoxicillin; amoxicillin/clavulanate potassium; azithromycin; cefaclor; cephalexin; cefdinir; or clindamycin) will be given at standard dosage that may be used for 7-10 days following surgery .

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

* Patients who are candidates for Adenotonsillectomy or Tonsillectomy only (AT/T). * Patient age 18 years or younger(if patient not 18 years, then parent/guardian will be the participant and must also meet inclusion criteria #3). * English as the primary language.

Exclusion criteria

* Patients not having English as their primary language * Patients \<18 years of age without a parent/guardian present. * Patients with periodic fever syndrome, immunocompromise, hemophilia, cerebral palsy, down syndrome, sickle cell disease, or with known preoperative aspiration.

Design outcomes

Primary

MeasureTime frameDescription
Healthcare Utilization6 wks post-operative appointmentQuestionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
Patients will receive postoperative antibiotic after surgery. Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery . Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
20
Control
Patients will NOT receive postoperative antibiotic No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics
24
Total44

Baseline characteristics

CharacteristicInterventionControlTotal
Age, Customized
<18 years
20 participants24 participants44 participants
Gender
Female
6 Participants12 Participants18 Participants
Gender
Male
14 Participants12 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 24
serious
Total, serious adverse events
0 / 200 / 24

Outcome results

Primary

Healthcare Utilization

Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.

Time frame: 6 wks post-operative appointment

ArmMeasureGroupValue (NUMBER)
InterventionHealthcare UtilizationMade a phone call to clinic5 participants
InterventionHealthcare UtilizationReceived additional antibiotic0 participants
InterventionHealthcare UtilizationER/UR/Clinic visit2 participants
InterventionHealthcare UtilizationDiagnostic workup at ER0 participants
InterventionHealthcare UtilizationReported Fever5 participants
ControlHealthcare UtilizationDiagnostic workup at ER6 participants
ControlHealthcare UtilizationReported Fever16 participants
ControlHealthcare UtilizationMade a phone call to clinic8 participants
ControlHealthcare UtilizationER/UR/Clinic visit9 participants
ControlHealthcare UtilizationReceived additional antibiotic6 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026