Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit

Rationale: Use of narcotics and benzodiazepines is common in the pediatric intensive care
unit (PICU) to alleviate pain and anxiety, especially for patients who are mechanically
ventilated. Pain control and sedation decrease oxygen consumption, facilitate mechanical
ventilation, ensure patient safety and help patients tolerate nursing care. However, these
medications can also have negative consequences. Patients receiving greater amounts of
pharmacologic sedation in the intensive care unit (ICU) have longer duration of mechanical
ventilation and ICU length of stay. In fact, daily interruption of sedation shortens
duration of mechanical ventilation and ICU length of stay. Sedatives have also been
associated with development of delirium in ICU patients and linked to delusional and
disturbing memories and post-traumatic stress disorder (PTSD) after recovery from critical
illness. Benzodiazepines and opiates are associated with abnormal sleep architecture.
Furthermore, patients experience tolerance, physical dependency and withdrawal from these
agents. Lastly, there is evidence that sedatives, anesthetics and opiates are associated
with neurotoxicity in animal studies leading to growing concern about the potential effects
of these agents on the developing brains of children.

Novel Approach: In light of these negative aspects of pharmacologic sedation, we are looking
for alternative ways to provide comfort to critically ill children in the PICU. Acupuncture
has been found to be effective in reducing anxiety, acute pain, procedural pain,
post-operative pain, chronic pain, headache, infant colic, and has been found to reduce
anesthetic requirement during surgery.

Study Plan: We plan to randomize patients 6 months - 17 yrs old who are receiving mechanical
ventilation in the PICU to either acupuncture or sham acupuncture as an adjunct to standard
of care pharmacologic sedation as prescribed by the PICU medical team caring for the
patients. Our hypothesis is that those patients receiving acupuncture will require less
medications to keep them comfortable. Our study is powered (80%) to detect a 33% decrease in
pharmacologic sedation/analgesia.

Inclusion Criteria:

- age ≥6 months to <18 years

- intubated and mechanically ventilated

- patient requires pharmacologic sedation/analgesia to tolerate mechanical ventilation

- ≤72 hours of mechanical ventilation at time of enrollment with anticipated need of
mechanical ventilation for at least ≥48 hours more (in order to be able to receive at
least one acupuncture session)

- approval of treating physician

Exclusion Criteria:

- underlying neurologic condition that could impact sedation/analgesia needs

- coagulopathy (inr ≥ 1.8) or history of spontaneous bruising

- thrombocytopenia (platelets <20,000 that has not been treated with a platelet
transfusion)

- hemodynamic instability (on continuous infusion of vasopressor or inotrope)

- sepsis or bacteremia on antibiotic therapy <24 hours

- severe generalized skin disorder (e.g., epidermolysis bullosa, Stevens-Johnson)

- ward of state

- being treated with therapeutic level of systemic anticoagulation (e.g., heparin with
unfractionated heparin activity level ≥0.3, enoxaparin with low molecular weight
heparin activity level ≥0.5, warfarin with inr ≥1.8)

- immunosuppressed (on chemotherapy {e.g., daunorubicin, vincristine},
immunosuppressive medications {e.g., sirolimus, tacrolimus, cyclosporine,
mycophenolate mofetil, high dose steroids >4mg/kg/day}, or immunosuppressive
biologics {e.g., thymoglobulin, etanercept, infliximab, adalimumab, rituximab})