Pediatric Laser Acupuncture and Renal Biopsy
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): Aculaser applied to kidney points; Aculaser applied to sham points
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Other intervention name(s): Aculaser: Microlight ML830; Aculaser: Microlight ML830
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Aculaser; Microlight ML830; Kidney biopsy; Pain; Anxiety; Sedation