An interventional study of Aculaser applied to kidney points and Aculaser applied to sham points in Pain and Anxiety, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to participants aged 7 Years to 25 Years. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
The purpose of this study is to test if treatment with laser therapy in pediatric patients undergoing renal biopsies will improve patient satisfaction of the overall procedure. In this study, the participant will receive a laser acupuncture treatment targeting either kidney acupoints or targeting "sham" points not associated with the kidney; the participant will not get both. Both treatment sessions are given by a certified medical acupuncturist. The patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure. All medication will be administered without regard for which group the participant has been randomized, as the treatment team will also be blinded.
Hypothesis:
We will test the hypothesis that treatment with laser acupuncture in patients undergoing renal biopsies will improve patient satisfaction of the overall procedure.
Specific Aims:
Specific Aim 1: Determine whether the use of laser acupuncture improves patient's overall satisfaction of renal biopsy.
Specific Aim 2: Determine whether the use of laser acupuncture decreases the amount of sedative medication given during renal biopsy.
At University of California San Francisco, there are approximately 100 pediatric renal biopsies per year. All of these patients receive sedation, which is prescribed and supervised by the pediatric pain and palliative care team, with either ketamine or fentanyl and versed. Child life is involved; however, many children still experience anxiety and/or pain with the procedure. Use of a modality such as aculaser which may decrease these symptoms could enhance their experience.
The term "laser" stands for light amplification by stimulated emission of radiation. In laser acupuncture, a low power, cold light produced by a low-level laser diode is used to stimulate an acupuncture point. As it is non-invasive, laser acupuncture is thought to be safer than needle acupuncture, especially in the setting of patients with blood-borne infectious diseases. In a systematic review analyzing the evidence to support the effectiveness of laser acupuncture, randomized control trials in which adults with soft tissue injury, acute or chronic pain condition, or any systemic illness were included. This review reports moderate level of evidence for treatment of myofascial pain and post-operative nausea/vomiting and limited evidence of the clinical effectiveness of treating chronic tension headaches. Of note, no complications of the use of aculaser were reported in this review (1).
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This study's enrollment of 81 is close to the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
The patient will receive aculaser, performed by licensed acupuncturist, to "sham" acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
Device: Aculaser applied to sham points
The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
Device: Aculaser applied to kidney points
The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
Also known as: Aculaser: Microlight ML830
The patient will receive aculaser, performed by licensed acupuncturist, to "sham" acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
Also known as: Aculaser: Microlight ML830
Patient Pain/Anxiety
The patient will complete a visual analog scale (rate 0-10) to assess pain after the procedure. Zero is no pain and 10 is worse pain. Change was calculated by baseline minus day one.
Time frame: 1 day
Parent Perception of Patient Pain Report
Parent Perception of Patient Pain, scale is from 0 to 10, minimum value is 0, maximum value is 10, higher scores mean better outcome.
Time frame: 1 day
| Milestone | Aculaser Applied to Sham Points | Aculaser Applied to Kidney Points |
|---|---|---|
| Started | 41 | 40 |
| Completed | 41 | 40 |
| Not completed | 0 | 0 |
The patient will complete a visual analog scale (rate 0-10) to assess pain after the procedure. Zero is no pain and 10 is worse pain. Change was calculated by baseline minus day one.
| units on a scale | Aculaser Applied to Sham Points | Aculaser Applied to Kidney Points |
|---|---|---|
| Patient Pain/Anxiety | -0.5 ± 0.5 | 0.8 ± 0.4 |
Parent Perception of Patient Pain, scale is from 0 to 10, minimum value is 0, maximum value is 10, higher scores mean better outcome.
| units on a scale | Aculaser Applied to Sham Points | Aculaser Applied to Kidney Points |
|---|---|---|
| Parent Perception of Patient Pain Report | 0.3 ± 0.5 | 2.3 ± 0.8 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aculaser Applied to Sham Points | — | 0/41 (0%) | 0/41 (0%) |
| Aculaser Applied to Kidney Points | — | 0/40 (0%) | 0/40 (0%) |
| Age, Customized(participants) | Aculaser Applied to Sham Points | Aculaser Applied to Kidney Points | Total |
|---|---|---|---|
| 7-25 years | 41 | 40 | 81 |
| Sex: Female, Male(Participants) | Aculaser Applied to Sham Points | Aculaser Applied to Kidney Points | Total |
|---|---|---|---|
| Female | 14 | 17 | 31 |
| Male | 27 | 23 | 50 |
| Region of Enrollment(participants) | Aculaser Applied to Sham Points | Aculaser Applied to Kidney Points | Total |
|---|---|---|---|
| United States | 41 | 40 | 81 |
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco