Status:
COMPLETED
Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Agitation
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
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 ac...
Detailed 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 contr...
Eligibility Criteria
Inclusion
- 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
- 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})
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01848158
Start Date
March 1 2013
End Date
June 1 2016
Last Update
August 13 2020
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105