Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- average daily sedation score [ Time Frame: duration of mechanical ventilation (maximum 14 days) ]The primary outcome measure is average daily sedation score starting from the first day of acupuncture till the day prior to extubation or 14 days, whichever is sooner. All opiates are converted to morphine equivalents using the following conversions to equal 1mg of morphine: 15µg fentanyl, 0.15mg hydromorphone, 0.3mg methadone, 20mg codeine. All benzodiazepines are converted to midazolam equivalents using the following conversions to equal 1mg of midazolam: 2mg diazepam, 0.33mg lorazepam. One point is given for each of the following: morphine or midazolam equivalents of 0.1mg/kg, pentobarbital 2mg/kg, chloral hydrate 50mg/kg, any propofol use, any phenobarbitol use. Use of any antihistamines receives a point score of 0.5. When this score was originally developed, dexmedetomidine was not part of the score. However, as use of dexmedetomidine has become much more prevalent, we have modified the sedation score such that 1μg/kg of dexmedetomidine is equivalent to 0.1mg/kg of lorazepam.
- skin ulceration at acupuncture sites [ Time Frame: duration of mechanical ventilation (14 days maximum) ]
- hematoma at acupuncture sites [ Time Frame: duration of mechanical ventilation (14 days maximum) ]
- cellulitis [ Time Frame: duration of mechanical ventilation (14 days maximum) ]
- bacteremia [ Time Frame: duration of mechanical ventilation (14 days maximum) ]
- septic shock [ Time Frame: duration of mechanical ventilation (14 days maximum) ]
- death [ Time Frame: duration of mechanical ventilation (14 days maximum) ]
|Study Start Date:||March 2013|
|Study Completion Date:||June 2016|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Acupuncture treatment three times per week for up to two weeks.
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.
Other Name: Pyonex Singles, Seirin® (0.20 mm diameter, 1.5 mm long)
Sham Comparator: Sham Acupuncture
Sham acupuncture three times per week for up to two weeks
Device: sham acupuncture
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 Name: Pyonex Singles, Seirin® (bandage only, no needle)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848158
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Jane L Di Gennaro, MD, MS||Seattle Children's Hopsital|
|Principal Investigator:||Anne Lynn, MD||Seattle Children's Hospital|