SnoringNCT01561703
Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use
A study testing Antibiotic in people with Snoring and Strep Throat, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Snoring, Strep Throat
- What is being tested?
- Antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Healthcare Utilization in Adenotonsillectomy Patients With Postoperative Antibiotic Administration Compared to Patients Without Antibiotic Administration
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.
Read the 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.
- Conditions
- Snoring, Strep Throat
- Being tested
- Antibiotic
- Keywords
- Healthcare utilization, Tonsillectomy, Adenoidectomy/Tonsillectomy, Antibiotics
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Also called Amoxicillin, Amoxicillin/ and clavulanate potassium/Augmentin, Azithromycin/Zithromax, Cefaclor/Ceclor
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 .
| Study group | Role | What they receive |
|---|---|---|
| Anitibiotic | Experimental | Patients will receive postoperative antibiotic after surgery. Receives: Drug: Antibiotic |
| Control | No intervention | Patients will NOT receive postoperative antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare Utilization
Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.
Measured: 6 wks post-operative appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliav Gov-Arie, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561703
- Sponsor's protocol ID
- 1200310
- Status last verified
- Nov 2016
- First submitted
- 16 Mar 2012
- Last updated
- 19 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Telian SA, Handler SD, Fleisher GR, Baranak CC, Wetmore RF, Potsic WP. The effect of antibiotic therapy on recovery after tonsillectomy in children. A controlled study. Arch Otolaryngol Head Neck Surg. 1986 Jun;112(6):610-5. doi: 10.1001/archotol.1986.03780060022002.
PubMed 3516177Colreavy MP, Nanan D, Benamer M, Donnelly M, Blaney AW, O'Dwyer TP, Cafferkey M. Antibiotic prophylaxis post-tonsillectomy: is it of benefit? Int J Pediatr Otorhinolaryngol. 1999 Oct 15;50(1):15-22. doi: 10.1016/s0165-5876(99)00228-1.
PubMed 10596882Krishna P, LaPage MJ, Hughes LF, Lin SY. Current practice patterns in tonsillectomy and perioperative care. Int J Pediatr Otorhinolaryngol. 2004 Jun;68(6):779-84. doi: 10.1016/j.ijporl.2004.01.010.
PubMed 15126019Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
PubMed 21493257
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Healthcare Utilization in Adenotonsillectomy Patients With Postoperative Antibiotic Administration Compared to Patients Without Antibiotic Administration
- ClinicalTrials.gov ID
- NCT01561703
- Acronym / sponsor ID
- 1200310
- Conditions
- Snoring, Strep Throat
- Keywords
- Healthcare utilization, Tonsillectomy, Adenoidectomy/Tonsillectomy, Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Posted 19 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anitibiotic | Experimental | Drug: AntibioticPatients will receive postoperative antibiotic after surgery. |
| Control | No intervention | –Patients will NOT receive postoperative antibiotic |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticAlso: Amoxicillin, Amoxicillin/ and clavulanate potassium/Augmentin, Azithromycin/Zithromax, Cefaclor/CeclorOne 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 . | Drug | Anitibiotic |
Primary outcome
Healthcare Utilization
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3516177Telian SA, Handler SD, Fleisher GR, Baranak CC, Wetmore RF, Potsic WP. The effect of antibiotic therapy on recovery after tonsillectomy in children. A controlled study. Arch Otolaryngol Head Neck Surg. 1986 Jun;112(6):610-5. doi: 10.1001/archotol.1986.03780060022002.
- Background: PubMed 10596882Colreavy MP, Nanan D, Benamer M, Donnelly M, Blaney AW, O'Dwyer TP, Cafferkey M. Antibiotic prophylaxis post-tonsillectomy: is it of benefit? Int J Pediatr Otorhinolaryngol. 1999 Oct 15;50(1):15-22. doi: 10.1016/s0165-5876(99)00228-1.
- Background: PubMed 15126019Krishna P, LaPage MJ, Hughes LF, Lin SY. Current practice patterns in tonsillectomy and perioperative care. Int J Pediatr Otorhinolaryngol. 2004 Jun;68(6):779-84. doi: 10.1016/j.ijporl.2004.01.010.
- Background: PubMed 21493257Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliav Gov-Arie, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic in people with Snoring and Strep Throat, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare Utilization (time frame: 6 wks post-operative appointment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01561703, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017; AzTrials last refreshed its copy on 5 Nov 2026.