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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 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.

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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.

Conditions Studied

Interventions

  • OTHER Standard of Care
  • DIETARY_SUPPLEMENT Honey

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2019-04-16
Est. Completion 2020-09-23
Phase NA

What the Registry Record Tells You About NCT03931395

The ClinicalTrials.gov registry entry for NCT03931395 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,754-participant average among 6 other Tonsillectomy trials with a reported enrollment target (87% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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