Clinical trial NCT01848158: Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit
Official title: Safety, Feasibility & Effectiveness of Acupuncture as an Adjunct to Pharmacologic Treatment for Sedation and Analgesia in Mechanically Ventilated PICU Patients - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agitation
Keywords: acupuncture
pediatric
critical care
mechanical ventilation
sedation
comfort
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 acupuncture will require less medications to keep them comfortable than those who receive sham or fake acupuncture.

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 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.

Eligibility criteria: 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})

Primary outcomes:
measure: Average Daily Dexmedetomidine mcg/kg/Day
timeFrame: from time of first acupuncture/sham treatment till time of extubation
measure: Average Daily Morphine Equivalents (mg/kg/Day)
timeFrame: from time of first acupuncture/sham treatment till time of extubation
measure: Average Daily Midazolam Equivalents (mg/kg/Day)
timeFrame: from time of first acupuncture/sham treatment till time of extubation
measure: Average Daily Sedation Score
timeFrame: from time of first acupuncture/sham treatment till time of extubation
Secondary outcomes:
measure: Number of Participants With Skin Ulceration at Acupuncture/Sham Sites
timeFrame: From time of first treatment through 2 to 3 days after last treatment.
measure: Number of Participants With Hematoma at Acupuncture/Sham Sites
timeFrame: From time of first treatment through 2 to 3 days after last treatment.
measure: Number of Participants With Cellulitis at Acupuncture/Sham Sites
timeFrame: From time of first treatment through 2 to 3 days after last treatment.
measure: Number of Participants Who Are Diagnosed With Bacteremia During the Study
timeFrame: From time of first treatment through 2 to 3 days after last treatment.
measure: Number of Participants Who Are Diagnosed With Septic Shock During the Study
timeFrame: From time of first treatment through 2 to 3 days after last treatment.
measure: Death While Enrolled in Study
timeFrame: From time of first treatment through 2 to 3 days after last treatment.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hopsital
name: Jane L Di Gennaro, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Anne Lynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kudchadkar SR, Berger J, Patel R, Barnes S, Twose C, Walker T, Mitchell R, Song J, Anton B, Punjabi NM. Non-pharmacological interventions for sleep promotion in hospitalized children. Cochrane Database Syst Rev. 2022 Jun 15;6(6):CD012908. doi: 10.1002/14651858.CD012908.pub2.