NCT03931395

Honey Used as Adjunct Therapy to Tylenol for Post-Op Tonsillectomy Patients

Completed NA Last updated 1 April 2021

What this trial tests

NA trial testing Honey in Tonsillectomy in 230 participants. Completed in 23 September 2020.

Timeline

16 April 2019

Primary endpoint
23 September 2020

23 September 2020

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	230
Start date	16 April 2019
Primary completion	23 September 2020
Estimated completion	23 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Honey — full drug profile →
• Standard of Care

Conditions studied

• Tonsillectomy — all drugs for Tonsillectomy →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 2 to 17, any sex, with Tonsillectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.