Tonsillitis
Conditions
Keywords
auricular, acupuncture, pain
Brief summary
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.
Detailed description
DESIGN: Design type: Prospective, randomized control trial Sample * Description of the population: All adults, greater than or equal to 18 years, undergoing a tonsillectomy with or without adenoidectomy at Womack Army Medical Center are eligible for participation in the study. * Sample Size: 100 subjects. A target of 45 subjects per group for a total of 90 subjects, and accounting for a 10 percent drop out rate. In Fiscal Year 12, 92 tonsilectomies in patients over the age of 12 were performed at Womack Army Medical Center. Therefore, the investigators anticipate the study will take up to 4 years to enroll 100 adult subjects. * Power Analysis: Under the assumption of a linear time by treatment interaction, assuming subject-level randomization, five time-points, power of 80 percent, a Type I error rate of 5 per cent and no attrition, to detect a 1.6 difference in pain score requires a total sample size of 90 subjects or 45 per treatment arm.
Interventions
OTHERAuricular 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.
Sponsors
Defense and Veterans Center for Integrative Pain Management
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All adults eighteen years of age or older having a tonsillectomy with or without adenoidectomy * Anesthesiologist classification one to three
Exclusion criteria
* Chronic pain syndromes or pain symptoms lasting greater than three months or taking opioids on a daily basis for greater than four months * Anesthesiologist classification four * Prior neck or throat surgery * Allergy to gold
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | 10 days after the procedure. | 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. |
| The Morphine Equivalent of Opioid Use | Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return to Diet | Within 10 days post operatively | Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them) |
| Number of Participants With Nausea Post Operatively | 1-3 hours postoperativey | It will be documented yes or no if the participant voiced any complaint of nausea while in recovery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| Group 2 Don't Receive Anything They do not receive any any acupuncture only standard of care. | 50 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 24 |
Baseline characteristics
| Characteristic | Group 2 Don't Receive Anything | Total | Group 1 - Receives Auricular Acupuncture |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 95 Participants | 45 Participants |
| Age, Continuous | 26 years | 25 years | 25 years |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Race Black or African American | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) Race More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 12 Participants | 19 Participants | 7 Participants |
| Race (NIH/OMB) Race White | 32 Participants | 59 Participants | 27 Participants |
| Region of Enrollment United States | 50 participants | 95 participants | 45 participants |
| Sex: Female, Male Female | 27 Participants | 51 Participants | 24 Participants |
| Sex: Female, Male Male | 23 Participants | 44 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 50 |
| other Total, other adverse events | 2 / 45 | 3 / 50 |
| serious Total, serious adverse events | 0 / 45 | 0 / 50 |
Outcome results
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.
Time frame: 10 days after the procedure.
Population: Only a 50 % diary return completing the full 10 day diary data but had the full inpatient data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Receives Auricular Acupuncture | Pain Scores | Pain at discharge | 1.3 units on a scale | Standard Deviation 1.6 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | Pain at 6 hours post discharge | 5.1 units on a scale | Standard Deviation 1.6 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | 12 hours post discharge | 5.5 units on a scale | Standard Deviation 1.9 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | 18hrs post discharge | 5.4 units on a scale | Standard Deviation 1.7 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | 24 hrs post discharge | 5.3 units on a scale | Standard Deviation 2.1 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | day 2 of discharge | 6.1 units on a scale | Standard Deviation 1.9 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | day 3 of discharge | 5.8 units on a scale | Standard Deviation 2.1 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | day 4 of discharge | 5.6 units on a scale | Standard Deviation 1.9 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | day 5 of discharge | 5.5 units on a scale | Standard Deviation 2.2 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | day 6 of discharge | 5.5 units on a scale | Standard Deviation 2.3 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | day 7 of discharge | 5.3 units on a scale | Standard Deviation 2.3 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | day 8 of discharge | 4.6 units on a scale | Standard Deviation 2.3 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | day 9 of discharge | 4.4 units on a scale | Standard Deviation 2.5 |
| Group 1 - Receives Auricular Acupuncture | Pain Scores | Day 10 of discharge | 3.6 units on a scale | Standard Deviation 2.1 |
| Group 2 Don't Receive Anything | Pain Scores | day 7 of discharge | 5.3 units on a scale | Standard Deviation 2.3 |
| Group 2 Don't Receive Anything | Pain Scores | Pain at discharge | 1.4 units on a scale | Standard Deviation 1.6 |
| Group 2 Don't Receive Anything | Pain Scores | day 4 of discharge | 5.6 units on a scale | Standard Deviation 1.9 |
| Group 2 Don't Receive Anything | Pain Scores | Pain at 6 hours post discharge | 5.9 units on a scale | Standard Deviation 2.1 |
| Group 2 Don't Receive Anything | Pain Scores | day 9 of discharge | 4.7 units on a scale | Standard Deviation 2.1 |
| Group 2 Don't Receive Anything | Pain Scores | 12 hours post discharge | 6.4 units on a scale | Standard Deviation 1.9 |
| Group 2 Don't Receive Anything | Pain Scores | day 5 of discharge | 6.3 units on a scale | Standard Deviation 1.9 |
| Group 2 Don't Receive Anything | Pain Scores | 18hrs post discharge | 6.4 units on a scale | Standard Deviation 1.6 |
| Group 2 Don't Receive Anything | Pain Scores | day 8 of discharge | 5.5 units on a scale | Standard Deviation 2.3 |
| Group 2 Don't Receive Anything | Pain Scores | 24 hrs post discharge | 6.0 units on a scale | Standard Deviation 2.1 |
| Group 2 Don't Receive Anything | Pain Scores | day 6 of discharge | 6.2 units on a scale | Standard Deviation 2.2 |
| Group 2 Don't Receive Anything | Pain Scores | day 2 of discharge | 6.5 units on a scale | Standard Deviation 2 |
| Group 2 Don't Receive Anything | Pain Scores | Day 10 of discharge | 3.9 units on a scale | Standard Deviation 2.2 |
| Group 2 Don't Receive Anything | Pain Scores | day 3 of discharge | 6.4 units on a scale | Standard Deviation 2.2 |
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.
Time frame: Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.
Population: Some results based on 10 day diary return but inpatient data available on all subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Receives Auricular Acupuncture | The Morphine Equivalent of Opioid Use | Oral morphine equivalent in OR in mg | 63.8 mg | Standard Deviation 2407 |
| Group 1 - Receives Auricular Acupuncture | The Morphine Equivalent of Opioid Use | oral morphine equivalent in PACU in mg | 9.1 mg | Standard Deviation 20 |
| Group 1 - Receives Auricular Acupuncture | The Morphine Equivalent of Opioid Use | oral morphine equivalent in mg 10 days post discha | 257.3 mg | Standard Deviation 341.7 |
| Group 1 - Receives Auricular Acupuncture | The Morphine Equivalent of Opioid Use | oral morphine equivalent total OR+ PACU+Home | 334.3 mg | Standard Deviation 339.4 |
| Group 2 Don't Receive Anything | The Morphine Equivalent of Opioid Use | oral morphine equivalent total OR+ PACU+Home | 376.2 mg | Standard Deviation 254.3 |
| Group 2 Don't Receive Anything | The Morphine Equivalent of Opioid Use | Oral morphine equivalent in OR in mg | 70.5 mg | Standard Deviation 24 |
| Group 2 Don't Receive Anything | The Morphine Equivalent of Opioid Use | oral morphine equivalent in mg 10 days post discha | 295.7 mg | Standard Deviation 257.8 |
| Group 2 Don't Receive Anything | The Morphine Equivalent of Opioid Use | oral morphine equivalent in PACU in mg | 7.4 mg | Standard Deviation 10.9 |
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.
Time frame: 1-3 hours postoperativey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - Receives Auricular Acupuncture | Number of Participants With Nausea Post Operatively | 6 Participants |
| Group 2 Don't Receive Anything | Number of Participants With Nausea Post Operatively | 3 Participants |
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.
Time frame: 1-3 hours post operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - Receives Auricular Acupuncture | Number of Participants With Nausea Post Operatively | 3 Participants |
| Group 2 Don't Receive Anything | Number of Participants With Nausea Post Operatively | 2 Participants |
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)
Time frame: Within 10 days post operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - Receives Auricular Acupuncture | Return to Diet | 10 days | Standard Deviation 1.9 |
| Group 2 Don't Receive Anything | Return to Diet | 10 days | Standard Deviation 1.9 |