TonsillectomyNCT04910919
Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery
A study testing Honey in people with Tonsillectomy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Tonsillectomy is one of the most common surgeries performed in the United States, with over half a million performed annually in children younger than 15 years of age. Postoperative pain is one of the most common clinical problems and may lead to poor intake, dehydration, and weight loss. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2022to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- english speaking
- children ages 5-17 years
Who cannot join
- any child with a genetic syndrome or developmental disability
- allergies to honey
- non-english speaking families
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
Tonsillectomy is one of the most common surgeries performed in the United States, with over half a million performed annually in children younger than 15 years of age. Postoperative pain is one of the most common clinical problems and may lead to poor intake, dehydration, and weight loss. Management of postoperative pain is often challenging and results in additional medical costs due to unplanned emergency room visits. Opioids such as codeine are commonly prescribed for pain control, however in 2013 the Food \& Drug Administration issued a black box warning for the use of codeine in post-tonsillectomy pediatric patients. The American Academy of Otolaryngology-Head and Neck Surgery recommends the use of acetaminophen and ibuprofen to successfully manage postoperative pain. With an extended recovery period, often longer than 7 days, alternative measures to reduce postoperative pain are needed. Honey has been proven to possess antibacterial and anti-inflammatory properties. This intervention will evaluate the effect of Tylenol, ibuprofen with honey on children's postoperative pain and nausea following tonsillectomy surgery.
Read the detailed description
This is a randomized intervention study where 100 pediatric tonsillectomy patients will received standard of care treatment for post-operative pain and randomized by their physician's standing orders on whether or not they include honey for pain management plus the standard of care alternating acetaminophen or Motrin dose (50 patients in the control group and 50 patients in the intervention group).
Patients/ families will be consented for the study during their clinic appointment, by the provider and/ or Registered Nurse (RN) after surgical intervention has been determined as the plan of care or day of surgery if the consent is not present on the EMR by the provider and/ or Holding Room RNs. They will be given a pain catastrophizing scale questionnaire to complete. Patient/ family will be instructed in the use of the medication, pain scale and nausea scale diary by the Holding Room RNs and again with the PACU RNs as they enter they first values before discharge to home. Patients admitted to an inpatient unit are excluded from the study.
The family will be called on post-op Day 1 and Day 4 to answer any questions concerning completing the diary. On Day 5, an image of the diary will be emailed by the family to the PACU for uploading into the secure REDCap database.
Control group families/ patients may call the physician's office postoperatively for pain support and a dose honey may be suggested for post-operative pain. These patients will be grouped into a separately and additional control patients will be enrolled until 50 control patients is achieved.
- Conditions
- Tonsillectomy
- Being tested
- Honey, Standard of Care
- Keywords
- honey, pediatrics, post-operative, pain, nausea, tonsillectomy, complimentary and alternative medicine
- Medical subject headings
- Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoneyDietary supplement
Participants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen.
Standard of CareOther
The first 50 participants will receive treatment as usual (alternating weight-based dosing of acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | The first 50 participants will receive treatment as usual (alternating weight-based dosing of acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic). Receives: Other: Standard of Care |
| Honey Intervention | Experimental | Participants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen. Receives: Dietary Supplement: Honey; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric value of post-operative pain measured by FACES pain scale
The post-operative pain is measured by the self-reported FACES pain scale. The range of scores is from 0-10. 0 (smiling face = no pain) and 10 (crying face) = worst pain ever. This scale is used by patients who are developmentally able, ages 5-9.
Measured: Post-operative day 0 to post-operative day 5.
Numeric value of post-operative pain measured by Visual Analog Scale (VAS) pain scale
The VAS uses a horizontal 10cm line with the extremes of "no pain at all" and "worst pain imaginable". The subject marks on the line their pain rating. Higher points indicate more severe or intense pain. This scale is used by patients who are developmentally able, ages 10-17.
Measured: Post-operative day 0 to post-operative day 5.
Numeric value of post-operative nausea measured by Baxter Animated Retching Faces (BARF) scale
Baxter Animated Retching Faces (BARF) scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).
Measured: Post-operative day 0 to post-operative day 5.
Secondary outcomes (1)
Beliefs and receptiveness of patient families on pain management measured with the catastrophizing scale
Families will be given a catastrophizing questionnaire to complete to understand their feelings about caring for their child in pain post-operatively. It is a 5 point likert scale that asks participants to select the word that best reflects how strongly they have each questionnaire thought (statement) when their child is in pain, such as 'When my child is in pain, I worry all the time about whether the pain will end', not at all to extremely.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study startMar 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: competing study started with same participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patti Runyan, Vanderbilt University Medical Center
- Investigators
- Patti Runyan, DNP, Study director, Monroe Carell Jr. Children's Hospital at Vanderbilt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910919
- Sponsor's protocol ID
- Buzz Study
- Status last verified
- Oct 2021
- First submitted
- 27 May 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery
- ClinicalTrials.gov ID
- NCT04910919
- Acronym / sponsor ID
- Buzz Study
- Conditions
- Tonsillectomy
- Keywords
- honey, pediatrics, post-operative, pain, nausea, tonsillectomy, complimentary and alternative medicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: competing study started with same participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tonsillectomy is one of the most common surgeries performed in the United States, with over half a million performed annually in children younger than 15 years of age. Postoperative pain is one of the most common clinical problems and may lead to poor intake, dehydration, and weight loss. Management of postoperative pain is often challenging and results in additional medical costs due to unplanned emergency room visits. Opioids such as codeine are commonly prescribed for pain control, however in 2013 the Food \& Drug Administration issued a black box warning for the use of codeine in post-tonsillectomy pediatric patients. The American Academy of Otolaryngology-Head and Neck Surgery recommends the use of acetaminophen and ibuprofen to successfully manage postoperative pain. With an extended recovery period, often longer than 7 days, alternative measures to reduce postoperative pain are needed. Honey has been proven to possess antibacterial and anti-inflammatory properties. This intervention will evaluate the effect of Tylenol, ibuprofen with honey on children's postoperative pain and nausea following tonsillectomy surgery.
Detailed description
This is a randomized intervention study where 100 pediatric tonsillectomy patients will received standard of care treatment for post-operative pain and randomized by their physician's standing orders on whether or not they include honey for pain management plus the standard of care alternating acetaminophen or Motrin dose (50 patients in the control group and 50 patients in the intervention group).
Patients/ families will be consented for the study during their clinic appointment, by the provider and/ or Registered Nurse (RN) after surgical intervention has been determined as the plan of care or day of surgery if the consent is not present on the EMR by the provider and/ or Holding Room RNs. They will be given a pain catastrophizing scale questionnaire to complete. Patient/ family will be instructed in the use of the medication, pain scale and nausea scale diary by the Holding Room RNs and again with the PACU RNs as they enter they first values before discharge to home. Patients admitted to an inpatient unit are excluded from the study.
The family will be called on post-op Day 1 and Day 4 to answer any questions concerning completing the diary. On Day 5, an image of the diary will be emailed by the family to the PACU for uploading into the secure REDCap database.
Control group families/ patients may call the physician's office postoperatively for pain support and a dose honey may be suggested for post-operative pain. These patients will be grouped into a separately and additional control patients will be enrolled until 50 control patients is achieved.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareThe first 50 participants will receive treatment as usual (alternating weight-based dosing of acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic). |
| Honey Intervention | Experimental | Dietary Supplement: Honey, Other: Standard of CareParticipants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- english speaking
- children ages 5-17 years
Key exclusion criteria (3 listed)
- any child with a genetic syndrome or developmental disability
- allergies to honey
- non-english speaking families
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 |
|---|---|---|
| HoneyParticipants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen. | Dietary supplement | Honey Intervention |
| Standard of CareThe first 50 participants will receive treatment as usual (alternating weight-based dosing of acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic). | Other | Honey Intervention, Standard of Care |
Primary outcome
Numeric value of post-operative pain measured by FACES pain scale
Time frame: Post-operative day 0 to post-operative day 5.
The post-operative pain is measured by the self-reported FACES pain scale. The range of scores is from 0-10. 0 (smiling face = no pain) and 10 (crying face) = worst pain ever. This scale is used by patients who are developmentally able, ages 5-9.
Numeric value of post-operative pain measured by Visual Analog Scale (VAS) pain scale
Time frame: Post-operative day 0 to post-operative day 5.
The VAS uses a horizontal 10cm line with the extremes of "no pain at all" and "worst pain imaginable". The subject marks on the line their pain rating. Higher points indicate more severe or intense pain. This scale is used by patients who are developmentally able, ages 10-17.
Numeric value of post-operative nausea measured by Baxter Animated Retching Faces (BARF) scale
Time frame: Post-operative day 0 to post-operative day 5.
Baxter Animated Retching Faces (BARF) scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).
1 secondary outcome
Beliefs and receptiveness of patient families on pain management measured with the catastrophizing scale
Time frame: Baseline to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Tonsillectomy
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Recruiting
Coblator Wand Comparative Analysis
Tonsillectomy, Adenoidectomy
Not yet recruitingPhase 4
Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management
Tonsillectomy, Pharyngoplasty
Not yet recruitingPhase 3
Postoperative Care After Tonsillectomy
Tonsillectomy, Bleeding
Not yet recruitingPhase 4
Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy
Postoperative Pain, Tonsillectomy
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.
Patti Runyan, DNP study director
Monroe Carell Jr. Children's Hospital at Vanderbilt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey in people with Tonsillectomy, run by Vanderbilt University Medical Center 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 2 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: withdrawn, as of the sponsor's last update on 7 Jul 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Numeric value of post-operative pain measured by FACES pain scale (time frame: Post-operative day 0 to post-operative day 5.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.