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Pediatric Laser Acupuncture and Renal Biopsy

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aculaser applied to kidney points
Aculaser applied to sham points
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Aculaser, Microlight ML830, Kidney biopsy, Pain, Anxiety, Sedation

Eligibility Criteria

7 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco Hospital
  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Aculaser applied to sham points

Aculaser applied to kidney points

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 13, 2013
Last Updated
January 13, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01879826
Brief Title
Pediatric Laser Acupuncture and Renal Biopsy
Official Title
Efficacy of Laser Therapy as an Adjuvant Treatment During Kidney Biopsies to Decrease Anxiety and Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Aculaser, Microlight ML830, Kidney biopsy, Pain, Anxiety, Sedation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aculaser applied to sham points
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Aculaser applied to kidney points
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Aculaser applied to kidney points
Other Intervention Name(s)
Aculaser: Microlight ML830
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Aculaser applied to sham points
Other Intervention Name(s)
Aculaser: Microlight ML830
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Pain/Anxiety
Description
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
Secondary Outcome Measure Information:
Title
Parent Perception of Patient Pain Report
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Kim, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20633458
Citation
Baxter GD, Bleakley C, McDonough S. Clinical effectiveness of laser acupuncture: a systematic review. J Acupunct Meridian Stud. 2008 Dec;1(2):65-82. doi: 10.1016/S2005-2901(09)60026-1.
Results Reference
background
PubMed Identifier
9924226
Citation
Schlager A, Offer T, Baldissera I. Laser stimulation of acupuncture point P6 reduces postoperative vomiting in children undergoing strabismus surgery. Br J Anaesth. 1998 Oct;81(4):529-32. doi: 10.1093/bja/81.4.529.
Results Reference
result
PubMed Identifier
18022318
Citation
Gottschling S, Meyer S, Gribova I, Distler L, Berrang J, Gortner L, Graf N, Shamdeen GM. Laser acupuncture in children with headache: a double-blind, randomized, bicenter, placebo-controlled trial. Pain. 2008 Jul 15;137(2):405-412. doi: 10.1016/j.pain.2007.10.004. Epub 2007 Nov 19.
Results Reference
result
PubMed Identifier
15971087
Citation
Resim S, Gumusalan Y, Ekerbicer HC, Sahin MA, Sahinkanat T. Effectiveness of electro-acupuncture compared to sedo-analgesics in relieving pain during shockwave lithotripsy. Urol Res. 2005 Aug;33(4):285-90. doi: 10.1007/s00240-005-0473-7. Epub 2005 Jun 22.
Results Reference
result
PubMed Identifier
27749608
Citation
Oates A, Benedict KA, Sun K, Brakeman PR, Lim J, Kim C. Laser acupuncture reduces pain in pediatric kidney biopsies: a randomized controlled trial. Pain. 2017 Jan;158(1):103-109. doi: 10.1097/j.pain.0000000000000734.
Results Reference
derived

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Pediatric Laser Acupuncture and Renal Biopsy

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