Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 18
Updated:11/18/2017
Start Date:November 15, 2017
End Date:September 2019
Contact:David Rosen, MD
Email:rosend@wvumedicine.org
Phone:304-598-4263

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This is a single site, randomized, blinded, sham controlled, parallel group study to identify
whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing
procedures on their congenital heart defects (CHD).

This investigation is a single site, randomized, blinded, sham controlled, parallel group
study to identify whether EA is a beneficial anesthesia adjunct in children undergoing
procedures on their congenital heart defects.

Study subjects age's birth to eighteen years, undergoing cardiac surgery for their congenital
heart lesions will be considered for entrance into the study. The randomized subjects will
receive either EA or sham during their surgery for CHD. Subjects are expected to remain in
the hospital 48 hours post procedure. Standard of care blood samples will be obtained
pre-operative and post-operative. The only study specific blood sample will be Troponin I
levels which will be obtained before surgery begins after the IV lines have been placed, and
6 hours after bypass. Urine samples will be obtained before surgery after placement of the
foley catheter and every 6 hours post bypass aortic cross clamp removal for 48 hours while
the foley catheter is still in place.

Inclusion Criteria:

- Patients 0-18 years of age undergoing procedures on their congenital heart defects.

Additionally, patients with coarctation of the aorta for repair will be considered as a
separate group and eligible for enrollment.

- Willing to provide written Assent/Consent in English.

Exclusion Criteria:

- Patients with skin lesions over more than 50% of EA sites.

- Patients in renal failure.

- Patients on chronic opioid therapy.

- Unwilling to provide written Assent/Consent in English.
We found this trial at
1
site
Morgantown, West Virginia 26506
(304) 293-0111
Phone: 304-598-4263
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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