Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit
Condition: Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional

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.
    

Intervention name(s): acupuncture; sham acupuncture
Intervention type(s): Device; Device
Intervention description(s): Patients randomized to active treatment will receive acupuncture treatment with press needles (small acupuncture needles manufactured with attached bandage that makes the needle flush with skin) at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a seed magnet at ear shen men position for 4 hours on treatment days.; Patients randomized to sham treatment will receive sham acupuncture with similarly appearing bandages placed without press needles attached at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a similarly appearing bandage without seed magnet underneath at ear shen men position for 4 hours on treatment days.
Other intervention name(s): Pyonex Singles, Seirin® (0.20 mm diameter, 1.5 mm long); Pyonex Singles, Seirin® (bandage only, no needle)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; pediatric; critical care; mechanical ventilation; sedation; comfort