Trial Outcomes & Findings for Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea (NCT NCT02571075)
NCT ID: NCT02571075
Last Updated: 2020-06-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
10 days after the procedure.
Results posted on
2020-06-09
Participant Flow
Participant milestones
| Measure |
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.
|
Group 2 Don't Receive Anything
They do not receive any any acupuncture only standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
50
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
20
|
24
|
Reasons for withdrawal
| Measure |
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.
|
Group 2 Don't Receive Anything
They do not receive any any acupuncture only standard of care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
24
|
Baseline Characteristics
Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea
Baseline characteristics by cohort
| Measure |
Group 1 - Receives Auricular Acupuncture
n=45 Participants
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.
|
Group 2 Don't Receive Anything
n=50 Participants
They do not receive any any acupuncture only standard of care.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
25 years
n=99 Participants
|
26 years
n=107 Participants
|
25 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · White
|
27 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
50 participants
n=107 Participants
|
95 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10 days after the procedure.Population: Only a 50 % diary return completing the full 10 day diary data but had the full inpatient data
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.
Outcome measures
| Measure |
Group 1 - Receives Auricular Acupuncture
n=45 Participants
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.
|
Group 2 Don't Receive Anything
n=50 Participants
They do not receive any any acupuncture only standard of care.
|
|---|---|---|
|
Pain Scores
Pain at discharge
|
1.3 units on a scale
Standard Deviation 1.6
|
1.4 units on a scale
Standard Deviation 1.6
|
|
Pain Scores
Pain at 6 hours post discharge
|
5.1 units on a scale
Standard Deviation 1.6
|
5.9 units on a scale
Standard Deviation 2.1
|
|
Pain Scores
12 hours post discharge
|
5.5 units on a scale
Standard Deviation 1.9
|
6.4 units on a scale
Standard Deviation 1.9
|
|
Pain Scores
18hrs post discharge
|
5.4 units on a scale
Standard Deviation 1.7
|
6.4 units on a scale
Standard Deviation 1.6
|
|
Pain Scores
24 hrs post discharge
|
5.3 units on a scale
Standard Deviation 2.1
|
6.0 units on a scale
Standard Deviation 2.1
|
|
Pain Scores
day 2 of discharge
|
6.1 units on a scale
Standard Deviation 1.9
|
6.5 units on a scale
Standard Deviation 2.0
|
|
Pain Scores
day 3 of discharge
|
5.8 units on a scale
Standard Deviation 2.1
|
6.4 units on a scale
Standard Deviation 2.2
|
|
Pain Scores
day 4 of discharge
|
5.6 units on a scale
Standard Deviation 1.9
|
5.6 units on a scale
Standard Deviation 1.9
|
|
Pain Scores
day 5 of discharge
|
5.5 units on a scale
Standard Deviation 2.2
|
6.3 units on a scale
Standard Deviation 1.9
|
|
Pain Scores
day 6 of discharge
|
5.5 units on a scale
Standard Deviation 2.3
|
6.2 units on a scale
Standard Deviation 2.2
|
|
Pain Scores
day 7 of discharge
|
5.3 units on a scale
Standard Deviation 2.3
|
5.3 units on a scale
Standard Deviation 2.3
|
|
Pain Scores
day 8 of discharge
|
4.6 units on a scale
Standard Deviation 2.3
|
5.5 units on a scale
Standard Deviation 2.3
|
|
Pain Scores
day 9 of discharge
|
4.4 units on a scale
Standard Deviation 2.5
|
4.7 units on a scale
Standard Deviation 2.1
|
|
Pain Scores
Day 10 of discharge
|
3.6 units on a scale
Standard Deviation 2.1
|
3.9 units on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Group 1 - Receives Auricular Acupuncture
n=45 Participants
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.
|
Group 2 Don't Receive Anything
n=50 Participants
They do not receive any any acupuncture only standard of care.
|
|---|---|---|
|
The Morphine Equivalent of Opioid Use
Oral morphine equivalent in OR in mg
|
63.8 mg
Standard Deviation 2407
|
70.5 mg
Standard Deviation 24.0
|
|
The Morphine Equivalent of Opioid Use
oral morphine equivalent in PACU in mg
|
9.1 mg
Standard Deviation 20.0
|
7.4 mg
Standard Deviation 10.9
|
|
The Morphine Equivalent of Opioid Use
oral morphine equivalent in mg 10 days post discha
|
257.3 mg
Standard Deviation 341.7
|
295.7 mg
Standard Deviation 257.8
|
|
The Morphine Equivalent of Opioid Use
oral morphine equivalent total OR+ PACU+Home
|
334.3 mg
Standard Deviation 339.4
|
376.2 mg
Standard Deviation 254.3
|
SECONDARY outcome
Timeframe: Within 10 days post operativelySubjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them)
Outcome measures
| Measure |
Group 1 - Receives Auricular Acupuncture
n=17 Participants
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.
|
Group 2 Don't Receive Anything
n=22 Participants
They do not receive any any acupuncture only standard of care.
|
|---|---|---|
|
Return to Diet
|
10 days
Standard Deviation 1.9
|
10 days
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 1-3 hours postoperativeyIt will be documented yes or no if the participant voiced any complaint of nausea while in recovery.
Outcome measures
| Measure |
Group 1 - Receives Auricular Acupuncture
n=45 Participants
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.
|
Group 2 Don't Receive Anything
n=50 Participants
They do not receive any any acupuncture only standard of care.
|
|---|---|---|
|
Number of Participants With Nausea Post Operatively
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1-3 hours post operativelyIt will be documented yes or no if the participant had any emesis while in recovery prior to discharge home.
Outcome measures
| Measure |
Group 1 - Receives Auricular Acupuncture
n=45 Participants
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.
|
Group 2 Don't Receive Anything
n=50 Participants
They do not receive any any acupuncture only standard of care.
|
|---|---|---|
|
Number of Participants With Nausea Post Operatively
|
3 Participants
|
2 Participants
|
Adverse Events
Group 1 - Receives Auricular Acupuncture
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2 Don't Receive Anything
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 - Receives Auricular Acupuncture
n=45 participants at risk
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.
|
Group 2 Don't Receive Anything
n=50 participants at risk
They do not receive any any acupuncture only standard of care.
|
|---|---|---|
|
General disorders
Emergency room visit
|
4.4%
2/45 • Number of events 2 • 3 years from first enrolled to final participant
|
6.0%
3/50 • Number of events 3 • 3 years from first enrolled to final participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place