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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931395
Recruitment Status : Active, not recruiting
First Posted : April 30, 2019
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Katherine Grierson, Vanderbilt University Medical Center

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.


Condition or disease Intervention/treatment Phase
Tonsillectomy Dietary Supplement: Honey Other: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Honey as Adjunct Therapy to Tylenol and Motrin in Treating Post-Operative Pain and Nausea Following Tonsillectomy
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: 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

Other: Standard of Care
Patients will receive standard post operative medications per surgeon

Active Comparator: 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).
Other: Standard of Care
Patients will receive standard post operative medications per surgeon




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931395


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Study Director: Elizabeth Card, MSN Nursing Research Consultant
Publications:

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Responsible Party: Katherine Grierson, Registered Nurse, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03931395    
Other Study ID Numbers: 190013
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine Grierson, Vanderbilt University Medical Center:
Honey
Pediatrics
Post-Operative