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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Seattle Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Lin Di Gennaro, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01848158
First received: May 2, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Agitation
Device: acupuncture
Device: sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • average daily sedation score [ Time Frame: duration of mechanical ventilation (maximum 14 days) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • skin ulceration at acupuncture sites [ Time Frame: duration of mechanical ventilation (14 days maximum) ] [ Designated as safety issue: Yes ]
  • hematoma at acupuncture sites [ Time Frame: duration of mechanical ventilation (14 days maximum) ] [ Designated as safety issue: Yes ]
  • cellulitis [ Time Frame: duration of mechanical ventilation (14 days maximum) ] [ Designated as safety issue: Yes ]
  • bacteremia [ Time Frame: duration of mechanical ventilation (14 days maximum) ] [ Designated as safety issue: Yes ]
  • septic shock [ Time Frame: duration of mechanical ventilation (14 days maximum) ] [ Designated as safety issue: Yes ]
  • death [ Time Frame: duration of mechanical ventilation (14 days maximum) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Acupuncture treatment three times per week for up to two weeks.
Device: acupuncture
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)

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

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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})
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848158

Contacts
Contact: Jane L Di Gennaro, MD 206-987-6988 jane.digennaro@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Jane L Di Gennaro, MD    206-987-6988    jane.digennaro@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Jane L Di Gennaro, MD Seattle Children's Hopsital
Principal Investigator: Anne Lynn, MD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Lin Di Gennaro, Jane L. Di Gennaro, MD, Assistant Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01848158     History of Changes
Other Study ID Numbers: 24849 Academic Enrichment Fund
Study First Received: May 2, 2013
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
acupuncture
pediatric
critical care
mechanical ventilation
sedation
comfort

ClinicalTrials.gov processed this record on November 20, 2014