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NCT Number: NCT03931395

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

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.

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Key information

Conditions

Tonsillectomy

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Standard of care

Other

Patients will receive standard post operative medications per surgeon

Primary outcomes

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

    Time frame: Baseline to 3 weeks

    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)

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

    Time frame: Baseline to 3 weeks

    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)

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

    Time frame: Baseline to 3 weeks

    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)

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

    Time frame: Baseline to 3 weeks

    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)

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

    Time frame: Baseline to 3 weeks

    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)

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

    Time frame: Baseline to 3 weeks

    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)

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

    Time frame: Baseline to 3 weeks

    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.

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

    Time frame: Baseline to 3 weeks

    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.

Secondary outcomes

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

    Time frame: Baseline to 3 weeks

    Families will be given a CAM questionnaire to complete. The questionnaire asks families to rate on a scale of strongly disagree to strongly agree and asks questions like "The more knowledge a person has about CAM, the more likely they are to use it" and "There are less side effects when taking natural remedies" Families who select strongly disagree = they definitely do not agree with the statement. If they select strongly agree = they very much agree with the statement. Families will get this survey at the beginning of the study and get it again at the end to evaluate if their statement responses have changed.

    The beliefs and attitudes toward CAM were measured based on a 7-point Likert scale, with 1 representing strongly agree and 7 representing strongly disagree; mean scores and standard deviation were calculated for each of the 13 items.

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

    Time frame: Baseline to 3 weeks

    Nursing staff will receive a voluntary survey containing the CAM belief scale. The survey asks nurses to rate on a scale of Strongly disagree to Strongly agree and asks questions such as "I assess my patient for CAM use" or "I believe that CAM has a role in my practice." Strongly disagree = they definitely do not agree with the statement, strongly agree = They strongly agree with the statement.

    The beliefs and attitudes toward CAM were measured based on a 7-point Likert scale, with 1 representing strongly agree and 7 representing strongly disagree; mean scores and standard deviation were calculated for each of the 13 items.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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