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NCT03931395 · ClinicalTrials.gov registry record · NA
Honey Used as Adjunct Therapy to Tylenol for Post-Op Tonsillectomy Patients
A NA study of Tonsillectomy, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 230
- Enrollment target
- 1
- Study location
NCT03931395: Completed NA study of Tonsillectomy, sponsored by Vanderbilt University Medical Center.
NCT03931395 is a NA study of Tonsillectomy that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 230 participants, below the 1,754-participant average among 6 other Tonsillectomy trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03931395, a NA study of Tonsillectomy, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 230 participants
- Enrollment target
- 1
- Study location
Study Summary
Tonsillectomies are the second most common surgery with over half a million procedures in the United States for 2006. Tonsillectomies are considered a painful surgical procedure performed on children resulting in pain and nausea/vomiting for up to 7 days postoperatively. Up until recently, doctors have been prescribing upwards of ten days' worth of opioid pain medication for children following tonsillectomies due to the high incidence of pain expected afterwards. Effective July 1st, 2018, new laws regarding opioid restrictions came into place that restricted doctor's abilities to write for more than three days' worth of opioid pain medication without having to fill out sizeable amounts of additional paperwork. This law was put in place to combat the ongoing opioid epidemic that plagues this country. What the investigators are left with for the treatment of pain following these procedures are simply Tylenol and Motrin with a limited amount of opioid. With this being considered a highly painful surgery with a difficult recovery, more options are needed to effectively treat pain and reduce the incidence of emergency room visits and phone calls to the clinic regarding pain control in the postoperative period. Studies in Europe have shown that honey is an effective adjunct treatment option in the reduction of pain in pediatric postoperative tonsillectomies. These studies are few and far between and more research needs to be conducted to validate these claims particularly in the United States where research on this subject has been extremely limited. Further, the extent to which families and health care providers in the United States would be receptive to using honey for children's postoperative pain is unclear since honey is considered a complementary and alternative medicine (CAM) intervention.
Primary Outcome
Parents will use the Numerical Rating scale to assess their Childs pain. The range is 0-10, 0=No pain and 10 = Worst pain ever. This scale is used for patients who are developmentally able (ages 9 and up)
Conditions Studied
Interventions
- OTHER Standard of Care
- DIETARY_SUPPLEMENT Honey
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2019-04-16 |
| Est. Completion | 2020-09-23 |
| Phase | NA |
What the finished NCT03931395 record still lists
NCT03931395 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 1,754-participant average among 6 other Tonsillectomy trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Tonsillectomy appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT03931395 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03931395 about?
NCT03931395 is a clinical study titled "Honey Used as Adjunct Therapy to Tylenol for Post-Op Tonsillectomy Patients". Tonsillectomies are the second most common surgery with over half a million procedures in the United States for 2006. Tonsillectomies are considered a painful surgical procedure performed on children resulting in pain and nausea/vomiting for up to 7 days postoperatively. Up until recently, doctors h...
What is the current status of trial NCT03931395?
This trial is currently completed. It is a NA study. The enrollment target is 230 participants. The study started on 2019-04-16. Estimated completion is 2020-09-23.
What conditions does trial NCT03931395 study?
This clinical trial studies the following conditions: Tonsillectomy.
What interventions are being tested in trial NCT03931395?
The interventions under investigation include: Standard of Care (OTHER), Honey (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03931395?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03931395 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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