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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety, Feasibility & Effectiveness of Acupuncture as an Adjunct to Pharmacologic Treatment for Sedation and Analgesia in Mechanically Ventilated PICU Patients - A Pilot Study

Conditions
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Agitation

Intervention / Treatment
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* Device: acupuncture
* Device: sham acupuncture


Participation Criteria
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Eligibility Criteria
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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})

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture treatment three times per week for up to two weeks. | Device: acupuncture<br>* 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.<br>* Other names: Pyonex Singles, Seirin® (0.20 mm diameter, 1.5 mm long);|
| Sham Comparator: Sham Acupuncture<br>Sham acupuncture three times per week for up to two weeks | Device: sham acupuncture<br>* 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.<br>* Other names: Pyonex Singles, Seirin® (bandage only, no needle);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Dexmedetomidine mcg/kg/Day | Measured total amount of dexmedetomidine received from time of first acupuncture or sham treatment to extubation, normalized per weight and time on study (1st study treatment to extubation). | from time of first acupuncture/sham treatment till time of extubation | 
| Average Daily Morphine Equivalents (mg/kg/Day) | Measured total amount of morphine equivalent received from time of first acupuncture or sham treatment to extubation, normalized per weight and time on study (1st study treatment to extubation). | from time of first acupuncture/sham treatment till time of extubation | 
| Average Daily Midazolam Equivalents (mg/kg/Day) | Measured total amount of midazolam equivalent received from time of first acupuncture or sham treatment to extubation, normalized per weight and time on study (1st study treatment to extubation). | from time of first acupuncture/sham treatment till time of extubation | 
| Average Daily Sedation Score | To capture a global view of sedation and account for the combination of medications received, we also calculated an average daily 'sedation score' normalized for weight from the time of first treatment through extubation. The sedation score is a summary measure of sedative and analgesic exposure for mechanically ventilated children in the ICU. This score incorporates opioids, benzodiazepines, barbiturates, chloral hydrate, propofol, and antihistamines. Morphine and midazolam equivalents of 0.1 mg/kg, pentobarbital 2 mg/kg, chloral hydrate 50 mg/kg, any propofol use, and any phenobarbitol use are each allocated one point, while any antihistamine use receives a score of 0.5 (Randolph 2002, Curley 2005). We modified this score to include dexmedetomidine, assigning 1 point for 1 μg/kg of dexmedetomidine. The minimum value possible is zero, and there is no pre-defined maximum value. A higher score indicates higher dose of sedation medications (normalized by weight). | from time of first acupuncture/sham treatment till time of extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Skin Ulceration at Acupuncture/Sham Sites |  | From time of first treatment through 2 to 3 days after last treatment. | 
| Number of Participants With Hematoma at Acupuncture/Sham Sites |  | From time of first treatment through 2 to 3 days after last treatment. | 
| Number of Participants With Cellulitis at Acupuncture/Sham Sites |  | From time of first treatment through 2 to 3 days after last treatment. | 
| Number of Participants Who Are Diagnosed With Bacteremia During the Study |  | From time of first treatment through 2 to 3 days after last treatment. | 
| Number of Participants Who Are Diagnosed With Septic Shock During the Study |  | From time of first treatment through 2 to 3 days after last treatment. | 
| Death While Enrolled in Study |  | From time of first treatment through 2 to 3 days after last treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, pediatric, critical care, mechanical ventilation, sedation, comfort