CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 230 enrolled
Drug / intervention
Honey +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03931395
NCT03931395N/ACompleted

Evaluation of Honey as Adjunct Therapy to Tylenol and Motrin in Treating Post-Operative Pain and Nausea Following Tonsillectomy

Vanderbilt University Medical Center·interventional·Posted Apr 30, 2019·Updated Apr 1, 2021

In Brief

A clinical study evaluating Honey and Standard of Care for Tonsillectomy. Completed, enrolled 230 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTonsillectomy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 30, 2019
Enrollment StartApr 16, 2019
Primary CompletionSep 23, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.2 years ago

Interventions

Honeydietary

Will give patients and families included in the honey standard of care group 40 packets of hospital approved honey to implement in the tonsillectomy post-operative care of the child

Standard of Careother

Patients will receive standard post operative medications per surgeon