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

Seattle Children's Healthcare System

Status

Completed

Conditions

Agitation

Treatments

Device: sham acupuncture

Device: acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01848158

24849 Academic Enrichment Fund

Details and patient eligibility

About

The purpose of this study is to determine whether acupuncture is effective at improving comfort in children on a ventilator in the intensive care unit. Our hypothesis is that the patients receiving acupuncture will require less medications to keep them comfortable than those who receive sham or fake acupuncture.

Full description

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.

Enrollment

17 patients

Sex

All

Ages

6 months to 17 years old

Volunteers

No Healthy Volunteers

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})