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Pediatric Laser Acupuncture and Renal Biopsy

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StatusCompleted
Sponsors
University of California, San Francisco

Keywords

Abstract

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.

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.

Dates

Last Verified: 12/31/2019
First Submitted: 06/12/2013
Estimated Enrollment Submitted: 06/12/2013
First Posted: 06/17/2013
Last Update Submitted: 01/12/2020
Last Update Posted: 01/21/2020
Date of first submitted results: 10/23/2016
Date of first submitted QC results: 01/12/2020
Date of first posted results: 01/21/2020
Actual Study Start Date: 06/30/2013
Estimated Primary Completion Date: 10/31/2015
Estimated Study Completion Date: 10/31/2015

Condition or disease

Pain
Anxiety

Intervention/treatment

Device: Aculaser applied to kidney points

Device: Aculaser applied to sham points

Phase

-

Arm Groups

ArmIntervention/treatment
Sham Comparator: 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.
Device: 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.
Experimental: 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.
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.

Eligibility Criteria

Ages Eligible for Study 7 Years To 7 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

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

Outcome

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

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