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

West Virginia University

Status: Completed

Conditions: Congenital Heart Defect

Treatments: Device: sham; Device: electro-acupuncture (EA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03297658

1610318932

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 59 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 0-18 years of age undergoing procedures on their congenital heart defects where an aortic cross clamp will be placed.

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 2 patient groups

electro-acupuncture (EA) intervention

Active Comparator group

Description:

Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects will receive electro-acupuncture (EA) (treatment) mixed frequency( continuous plus dense disperse) will be at 2Hz and 100 Hz the amplitude will be 1000 microA.

Treatment:

Device: electro-acupuncture (EA)

sham electro acupuncture

Sham Comparator group

Description:

Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects Receive sham (control) will not have stimulation.

Treatment:

Device: sham