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

NCT ID: NCT03931395

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2020-09-23

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.

Conditions

Tonsillectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Honey Plus Standard of Care

The Honey standard of care group will receive treatment as usual, alternating acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic, plus 1 tsp of honey with every dose of acetaminophen. The Honey standard of care group will receive the first dose of honey in the recovery room with the administration of acetaminophen and will be provided with honey upon discharge.

Group Type: EXPERIMENTAL

Honey

Intervention Type: DIETARY_SUPPLEMENT

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 Care

Intervention Type: OTHER

Patients will receive standard post operative medications per surgeon

Standard of Care

The standard of care group will receive treatment as usual (alternating acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic).

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Patients will receive standard post operative medications per surgeon

Interventions

Honey

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

Intervention Type: DIETARY_SUPPLEMENT

Standard of Care

Patients will receive standard post operative medications per surgeon

Intervention Type: OTHER

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Katherine Grierson

Registered Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Card, MSN

Role: STUDY_DIRECTOR

Nursing Research Consultant

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 21324535 (View on PubMed)

Ozlugedik S, Genc S, Unal A, Elhan AH, Tezer M, Titiz A. Can postoperative pains following tonsillectomy be relieved by honey? A prospective, randomized, placebo controlled preliminary study. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1929-34. doi: 10.1016/j.ijporl.2006.07.001. Epub 2006 Aug 17.

Reference Type: BACKGROUND

PMID: 16914210 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 7524009 (View on PubMed)

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Reference Type: BACKGROUND

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Gabalski EC, Mattucci KF, Setzen M, Moleski P. Ambulatory tonsillectomy and adenoidectomy. Laryngoscope. 1996 Jan;106(1 Pt 1):77-80. doi: 10.1097/00005537-199601000-00015.

Reference Type: BACKGROUND

PMID: 8544633 (View on PubMed)

Other Identifiers

190013

Identifier Type: -

Identifier Source: org_study_id