Anxiety, Pain
Conditions
Keywords
Aculaser, Microlight ML830, Kidney biopsy, Pain, Anxiety, Sedation
Brief summary
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.
Detailed description
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). 1\. Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82.
Interventions
DEVICEAculaser 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.
DEVICEAculaser applied to sham points
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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* older than 6 years old * admitted for a transplant or native kidney biopsy performed by pediatric nephrology
Exclusion criteria
* Prisoners * Pregnant females * Those who are unable to participate with the visual analog scale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain/Anxiety | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Perception of Patient Pain Report | 1 day | Parent Perception of Patient Pain, scale is from 0 to 10, minimum value is 0, maximum value is 10, higher scores mean better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aculaser Applied to Sham Points 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.
Aculaser applied to sham points: 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. | 41 |
| 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.
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. | 40 |
| Total | 81 |
Baseline characteristics
| Characteristic | Aculaser Applied to Sham Points | Aculaser Applied to Kidney Points | Total |
|---|---|---|---|
| Age, Customized 7-25 years | 41 participants | 40 participants | 81 participants |
| Region of Enrollment United States | 41 participants | 40 participants | 81 participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Male | 27 Participants | 23 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 40 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 |
Outcome results
Primary
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
Population: Number of participants in the final analysis were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aculaser Applied to Sham Points | Patient Pain/Anxiety | -0.5 units on a scale | Standard Error 0.5 |
| Aculaser Applied to Kidney Points | Patient Pain/Anxiety | 0.8 units on a scale | Standard Error 0.4 |
p-value: 0.044t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aculaser Applied to Sham Points | Parent Perception of Patient Pain Report | 0.3 units on a scale | Standard Error 0.5 |
| Aculaser Applied to Kidney Points | Parent Perception of Patient Pain Report | 2.3 units on a scale | Standard Error 0.8 |
p-value: 0.04t-test, 2 sided