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The purpose of this study is to determine if auricular acupuncture significantly reduces post-operative pain in comparison to the standard of care. Post-operative pain score will be collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no pain, 10 = worst imaginable pain) up to 10 days post-operation.
DESIGN:
Design type: Prospective, randomized control trial Sample
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Receives auricular acupuncture | Experimental | Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened. |
|
| Group 2 don't receive anything | No Intervention | They do not receive any any acupuncture only standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular acupuncture | Other | The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Pain scores will be collected daily during the post op period in the recovery room using a numbers scale with faces; specifically the Wong-Baker FACES® Pain Rating Scale where 10 is described as worst possible and 0 is No pain. This was recorded by the participant at home using the same type scale and this was is provided to them. The Hypothesis is that subjects receiving intraoperative auricular acupuncture during a tonsillectomy will have statistically significantly less post-operative pain scores compared to those that do not. | 10 days after the procedure. |
| The Morphine Equivalent of Opioid Use | The intraoperative and recovery room morphine equivalents will be calculated and upon diary return what use is recorded by the patient will be done as well. The participant is instructed to write down the type and amount they take throughout that time period. | Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system. |
| Measure | Description | Time Frame |
|---|---|---|
| Return to Diet | Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them) | Within 10 days post operatively |
| Number of Participants With Nausea Post Operatively |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anthony R Plunkett, MD | Womack Army Medical Center Fort Bragg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womack Army Medical Center | Fort Bragg | North Carolina | 28310 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Receives Auricular Acupuncture | Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened. Auricular acupuncture: The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin. |
| FG001 | Group 2 Don't Receive Anything | They do not receive any any acupuncture only standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Receives Auricular Acupuncture | Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened. Auricular acupuncture: The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scores | Pain scores will be collected daily during the post op period in the recovery room using a numbers scale with faces; specifically the Wong-Baker FACES® Pain Rating Scale where 10 is described as worst possible and 0 is No pain. This was recorded by the participant at home using the same type scale and this was is provided to them. The Hypothesis is that subjects receiving intraoperative auricular acupuncture during a tonsillectomy will have statistically significantly less post-operative pain scores compared to those that do not. | Only a 50 % diary return completing the full 10 day diary data but had the full inpatient data | Posted | Mean | Standard Deviation | units on a scale | 10 days after the procedure. |
|
3 years from first enrolled to final participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Receives Auricular Acupuncture | Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened. Auricular acupuncture: The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency room visit | General disorders | MedDRA (10.0) | Non-systematic Assessment | bleeding |
Of the 95 enrolled there was only a 50% diary return of the 10 day diaries and not all of those were complete.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Plunkett | Womack Army Medical Center | 910-643-2324 | anthony.r.plunkett.civ@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2017 | Sep 12, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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It will be documented yes or no if the participant voiced any complaint of nausea while in recovery.
| 1-3 hours postoperativey |
| Number of Participants With Nausea Post Operatively | It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home. | 1-3 hours post operatively |
| BG001 | Group 2 Don't Receive Anything | They do not receive any any acupuncture only standard of care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Group 2 Don't Receive Anything | They do not receive any any acupuncture only standard of care. |
|
|
| Primary | The Morphine Equivalent of Opioid Use | The intraoperative and recovery room morphine equivalents will be calculated and upon diary return what use is recorded by the patient will be done as well. The participant is instructed to write down the type and amount they take throughout that time period. | Some results based on 10 day diary return but inpatient data available on all subjects | Posted | Mean | Standard Deviation | mg | Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system. |
|
|
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| Secondary | Return to Diet | Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them) | Posted | Mean | Standard Deviation | days | Within 10 days post operatively |
|
|
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| Secondary | Number of Participants With Nausea Post Operatively | It will be documented yes or no if the participant voiced any complaint of nausea while in recovery. | Posted | Count of Participants | Participants | 1-3 hours postoperativey |
|
|
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| Secondary | Number of Participants With Nausea Post Operatively | It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home. | Posted | Count of Participants | Participants | 1-3 hours post operatively |
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|
| 0 |
| 45 |
| 0 |
| 45 |
| 2 |
| 45 |
| EG001 | Group 2 Don't Receive Anything | They do not receive any any acupuncture only standard of care. | 0 | 50 | 0 | 50 | 3 | 50 |
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| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| oral morphine equivalent in PACU in mg |
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| oral morphine equivalent in mg 10 days post discha |
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| oral morphine equivalent total OR+ PACU+Home |
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