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

NCT03931395 | Completed

• 1 other identifier: 190013
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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

Keywords

Honey; Pediatrics; Post-Operative

Outcome Measures

Primary Outcomes (8)

• Pain scores as assessed by the Numerical Rating scale in participants who are given honey.

  Parents will use the Numerical Rating scale to assess their Childs pain. The range is 0-10, 0=No pain and 10 = Worst pain ever. This scale is used for patients who are developmentally able (ages 9 and up)

  Baseline to 3 weeks

• Pain scores as assessed by the Wong-Baker FACES scale in participants who are given honey.

  Parents will use the FACES pain scale. They will have the child choose between a range of faces that indicate a pain score of 0-10, 0 (a smiling face) = no pain and 10 (crying face) = worst pain ever. This scale is used for patients who are developmentally able (ages 3-9)

  Baseline to 3 weeks

• Pain scores as assessed by the FLACC scale in participants who are given honey.

  Parents will use use the FLACC pain scale, 0 = No pain and 10 = Worst pain ever. This scale will be used in children who developmentally can not rate their own pain (ages 2 months to 7 years)

  Baseline to 3 weeks

• Pain scores as assessed by the Numerical Rating scale in participants who receive standard of care (Tylenol, motoring & oxycodone).

  Parents will use the numerical rating scale to assess their Childs pain. The range is 0-10, 0=No pain and 10 = Worst pain ever. This scale is used for patients who are developmentally able (ages 9 and up)

  Baseline to 3 weeks

• Pain scores as assessed by the Wong-Baker FACES scale in participants who receive standard of care (Tylenol, motoring & oxycodone).

  Parents will use the FACES pain scale. They will have the child choose between a range of faces that indicate a pain score of 0-10, 0 (a smiling face) = no pain and 10 (crying face) = worst pain ever. This scale is used for patients who are developmentally able (ages 3-9)

  Baseline to 3 weeks

• Pain scores as assessed by the FLACC scale in participants who receive standard of care (Tylenol, motoring & oxycodone).

  Parents will use use the FLACC pain scale, 0 = No pain and 10 = Worst pain ever. This scale will be used in children who developmentally can not rate their own pain (ages 2 months to 7 years)

  Baseline to 3 weeks

• Nausea scores as assessed by the baxter barf scale in participants who receive honey.

  Parents will use the baxter barf scale by selecting or having their child select a face that represents nausea on a scale of 0 to 10, 0 = no nausea and 10 = actively vomiting.

  Baseline to 3 weeks

• Nausea scores as assessed by the baxter barf scale in participants who receive standard of care.

  Parents will use the baxter barf scale by selecting or having their child select a face that represents nausea on a scale of 0 to 10, 0 = no nausea and 10 = actively vomiting.

  Baseline to 3 weeks

Secondary Outcomes (2)

• Beliefs and receptiveness of patient families to complementary and alternative medicine (CAM) and use of honey.

  Baseline to 3 weeks

• The relation between the beliefs and receptiveness of nursing staff to complementary and alternative medicine (CAM) and use of honey.

  Baseline to 3 weeks

Study Arms (2)

Honey Plus Standard of Care

EXPERIMENTAL

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.

Dietary Supplement: Honey; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Honey 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

Honey Plus Standard of Care

Standard of Care OTHER

Patients will receive standard post operative medications per surgeon

Honey Plus Standard of Care; Standard of Care

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• English-speaking families
• male or female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (9)

• Jaryszak EM, Lander L, Patel AK, Choi SS, Shah RK. Prolonged recovery after out-patient pediatric adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2011 Apr;75(4):585-8. doi: 10.1016/j.ijporl.2011.01.024. Epub 2011 Feb 15.

  PMID: 21324535 BACKGROUND

• 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.

  PMID: 16914210 BACKGROUND

• Boroumand P, Zamani MM, Saeedi M, Rouhbakhshfar O, Hosseini Motlagh SR, Aarabi Moghaddam F. Post tonsillectomy pain: can honey reduce the analgesic requirements? Anesth Pain Med. 2013 Summer;3(1):198-202. doi: 10.5812/aapm.9246. Epub 2013 Jul 1.

  PMID: 24223362 BACKGROUND

• Bardy J, Slevin NJ, Mais KL, Molassiotis A. A systematic review of honey uses and its potential value within oncology care. J Clin Nurs. 2008 Oct;17(19):2604-23. doi: 10.1111/j.1365-2702.2008.02304.x.

  PMID: 18808626 BACKGROUND

• Abdullah B, Lazim NM, Salim R. The effectiveness of Tualang honey in reducing post-tonsillectomy pain. Kulak Burun Bogaz Ihtis Derg. 2015;25(3):137-43. doi: 10.5606/kbbihtisas.2015.00008.

  PMID: 26050853 BACKGROUND

• Mohebbi S, Nia FH, Kelantari F, Nejad SE, Hamedi Y, Abd R. Efficacy of honey in reduction of post tonsillectomy pain, randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1886-9. doi: 10.1016/j.ijporl.2014.08.018. Epub 2014 Aug 21.

  PMID: 25193590 BACKGROUND

• Gedaly-Duff V, Ziebarth D. Mothers' management of adenoid-tonsillectomy pain in 4- to 8-year-olds: a preliminary study. Pain. 1994 Jun;57(3):293-299. doi: 10.1016/0304-3959(94)90004-3.

  PMID: 7524009 BACKGROUND

• Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.

  PMID: 8867249 BACKGROUND

• 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.

  PMID: 8544633 BACKGROUND

MeSH Terms

Interventions

Honey; Standard of Care

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elizabeth Card, MSN

  Nursing Research Consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 30, 2019
• Study Start: April 16, 2019
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)