Clinical trial NCT03931395: Honey Used as Adjunct Therapy to Tylenol for Post-Op Tonsillectomy Patients
Official title: Evaluation of Honey as Adjunct Therapy to Tylenol and Motrin in Treating Post-Operative Pain and Nausea Following Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Keywords: Honey
Pediatrics
Post-Operative
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 230
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* English-speaking families
* male or female
* 2-17 years old undergoing a routine tonsillectomy procedure.
* English speaking families in the waiting room whose children are having any type of surgery during the time period we are enrolling the tonsillectomy patients.

Exclusion Criteria:

* Subjects will be excluded for any of the following reasons: Any child undergoing or has already undergone a tonsillectomy who has a genetic syndrome or developmental disability (e.g., Trisomy 21, Angelman Syndrome, etc.) which could impact the course of postoperative pain management.
* Any child who has an allergy to honey.
* Non English speaking families.

Primary outcomes:
measure: Pain scores as assessed by the Numerical Rating scale in participants who are given honey.
timeFrame: Baseline to 3 weeks
measure: Pain scores as assessed by the Wong-Baker FACES scale in participants who are given honey.
timeFrame: Baseline to 3 weeks
measure: Pain scores as assessed by the FLACC scale in participants who are given honey.
timeFrame: Baseline to 3 weeks
measure: Pain scores as assessed by the Numerical Rating scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
timeFrame: Baseline to 3 weeks
measure: Pain scores as assessed by the Wong-Baker FACES scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
timeFrame: Baseline to 3 weeks
measure: Pain scores as assessed by the FLACC scale in participants who receive standard of care (Tylenol, motoring & oxycodone).
timeFrame: Baseline to 3 weeks
measure: Nausea scores as assessed by the baxter barf scale in participants who receive honey.
timeFrame: Baseline to 3 weeks
measure: Nausea scores as assessed by the baxter barf scale in participants who receive standard of care.
timeFrame: Baseline to 3 weeks
Secondary outcomes:
measure: Beliefs and receptiveness of patient families to complementary and alternative medicine (CAM) and use of honey.
timeFrame: Baseline to 3 weeks
measure: The relation between the beliefs and receptiveness of nursing staff to complementary and alternative medicine (CAM) and use of honey.
timeFrame: Baseline to 3 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Nursing Research Consultant
name: Elizabeth Card, MSN
role: STUDY_DIRECTOR
References:
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