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临床试验/NCT01561703
NCT01561703已完成不适用

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

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2012年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Healthcare Utilization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Anitibiotic

Experimental

Patients will receive postoperative antibiotic after surgery.

干预措施: Antibiotic (Drug)

结局指标

主要结局

Healthcare Utilization

时间窗: 6 wks post-operative appointment

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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