An interventional study of Auricular acupuncture in Tonsillitis, sponsored by Defense and Veterans Center for Integrative Pain Management. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Defense and Veterans Center for Integrative Pain Management · Not applicable, Interventional, and Treatment
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
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 95 is close to the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Defense and Veterans Center for Integrative Pain Management is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.
Other: Auricular acupuncture
They do not receive any any acupuncture only standard of care.
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.
Also known as: "Battlefield Acupuncture" BFA
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.
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.
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
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
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
| Milestone | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything |
|---|---|---|
| Started | 45 | 50 |
| Completed | 25 | 26 |
| Not completed | 20 | 24 |
| Withdrew: Lost to follow-up | 20 | 24 |
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.
| units on a scale | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything |
|---|---|---|
| Pain at discharge | 1.3 ± 1.6 | 1.4 ± 1.6 |
| Pain at 6 hours post discharge | 5.1 ± 1.6 | 5.9 ± 2.1 |
| 12 hours post discharge | 5.5 ± 1.9 | 6.4 ± 1.9 |
| 18hrs post discharge | 5.4 ± 1.7 | 6.4 ± 1.6 |
| 24 hrs post discharge | 5.3 ± 2.1 | 6.0 ± 2.1 |
| day 2 of discharge | 6.1 ± 1.9 | 6.5 ± 2.0 |
| day 3 of discharge | 5.8 ± 2.1 | 6.4 ± 2.2 |
| day 4 of discharge | 5.6 ± 1.9 | 5.6 ± 1.9 |
| day 5 of discharge | 5.5 ± 2.2 | 6.3 ± 1.9 |
| day 6 of discharge | 5.5 ± 2.3 | 6.2 ± 2.2 |
| day 7 of discharge | 5.3 ± 2.3 | 5.3 ± 2.3 |
| day 8 of discharge | 4.6 ± 2.3 | 5.5 ± 2.3 |
| day 9 of discharge | 4.4 ± 2.5 | 4.7 ± 2.1 |
| Day 10 of discharge | 3.6 ± 2.1 | 3.9 ± 2.2 |
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.
| mg | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything |
|---|---|---|
| Oral morphine equivalent in OR in mg | 63.8 ± 2407 | 70.5 ± 24.0 |
| oral morphine equivalent in PACU in mg | 9.1 ± 20.0 | 7.4 ± 10.9 |
| oral morphine equivalent in mg 10 days post discha | 257.3 ± 341.7 | 295.7 ± 257.8 |
| oral morphine equivalent total OR+ PACU+Home | 334.3 ± 339.4 | 376.2 ± 254.3 |
Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them)
| days | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything |
|---|---|---|
| Return to Diet | 10 ± 1.9 | 10 ± 1.9 |
It will be documented yes or no if the participant voiced any complaint of nausea while in recovery.
| Participants | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything |
|---|---|---|
| Number of Participants With Nausea Post Operatively | 6 | 3 |
It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home.
| Participants | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything |
|---|---|---|
| Number of Participants With Nausea Post Operatively | 3 | 2 |
Collected over 3 years from first enrolled to final participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 - Receives Auricular Acupuncture | 0/45 (0%) | 0/45 (0%) | 2/45 (4.4%) |
| Group 2 Don't Receive Anything | 0/50 (0%) | 0/50 (0%) | 3/50 (6%) |
| Event | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything |
|---|---|---|
| Emergency room visitGeneral disorders | 2/45 | 3/50 |
| Age, Categorical(Participants) | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 50 | 95 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything | Total |
|---|---|---|---|
| Mean | 25 (22 to 30) | 26 (22 to 29) | 25 (22 to 30) |
| Sex: Female, Male(Participants) | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything | Total |
|---|---|---|---|
| Female | 24 | 27 | 51 |
| Male | 21 | 23 | 44 |
| Race (NIH/OMB)(Participants) | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything | Total |
|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | 0 |
| Race — Asian | 2 | 1 | 3 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race — Black or African American | 9 | 5 | 14 |
| Race — White | 27 | 32 | 59 |
| Race — More than one race | 0 | 0 | 0 |
| Race — Unknown or Not Reported | 7 | 12 | 19 |
| Region of Enrollment(participants) | Group 1 - Receives Auricular Acupuncture | Group 2 Don't Receive Anything | Total |
|---|---|---|---|
| United States | 45 | 50 | 95 |
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Defense and Veterans Center for Integrative Pain Management