AgitationNCT01848158
Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit
A study testing acupuncture in people with Agitation, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Agitation
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
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- 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})
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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
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.
Read the 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.
- Conditions
- Agitation
- Being tested
- acupuncture, sham acupuncture
- Keywords
- acupuncture, pediatric, critical care, mechanical ventilation, sedation, comfort
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Also called Pyonex Singles, Seirin® (0.20 mm diameter, 1.5 mm long)
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.
sham acupunctureDevice
Also called Pyonex Singles, Seirin® (bandage only, no needle)
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture treatment three times per week for up to two weeks. Receives: Device: acupuncture |
| Sham Acupuncture | Sham comparator | Sham acupuncture three times per week for up to two weeks Receives: Device: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: from time of first acupuncture/sham treatment till time of extubation
Secondary outcomes (6)
Number of Participants With Skin Ulceration at Acupuncture/Sham Sites
Measured: From time of first treatment through 2 to 3 days after last treatment.
Number of Participants With Hematoma at Acupuncture/Sham Sites
Measured: From time of first treatment through 2 to 3 days after last treatment.
Number of Participants With Cellulitis at Acupuncture/Sham Sites
Measured: From time of first treatment through 2 to 3 days after last treatment.
Number of Participants Who Are Diagnosed With Bacteremia During the Study
Measured: 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
Measured: From time of first treatment through 2 to 3 days after last treatment.
Death While Enrolled in Study
Measured: From time of first treatment through 2 to 3 days after last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Di Gennaro, Seattle Children's Hospital
- Investigators
- Jane L Di Gennaro, MD, MS, Principal investigator, Seattle Children's HopsitalAnne Lynn, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848158
- Sponsor's protocol ID
- 24849 Academic Enrichment Fund
- Status last verified
- Aug 2020
- First submitted
- 2 May 2013
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35703367
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01848158
- Acronym / sponsor ID
- 24849 Academic Enrichment Fund
- Conditions
- Agitation
- Keywords
- acupuncture, pediatric, critical care, mechanical ventilation, sedation, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: acupunctureAcupuncture treatment three times per week for up to two weeks. |
| Sham Acupuncture | Sham comparator | Device: sham acupunctureSham acupuncture three times per week for up to two weeks |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: Pyonex Singles, Seirin® (0.20 mm diameter, 1.5 mm long)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. | Device | Acupuncture |
| sham acupunctureAlso: Pyonex Singles, Seirin® (bandage only, no needle)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. | Device | Sham Acupuncture |
Primary outcome
Average Daily Dexmedetomidine mcg/kg/Day
Time frame: from time of first acupuncture/sham treatment till time of extubation
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).
Average Daily Morphine Equivalents (mg/kg/Day)
Time frame: from time of first acupuncture/sham treatment till time of extubation
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).
Average Daily Midazolam Equivalents (mg/kg/Day)
Time frame: from time of first acupuncture/sham treatment till time of extubation
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).
Average Daily Sedation Score
Time frame: from time of first acupuncture/sham treatment till time of extubation
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).
6 secondary outcomes
Number of Participants With Skin Ulceration at Acupuncture/Sham Sites
Time frame: From time of first treatment through 2 to 3 days after last treatment.
Number of Participants With Hematoma at Acupuncture/Sham Sites
Time frame: From time of first treatment through 2 to 3 days after last treatment.
Number of Participants With Cellulitis at Acupuncture/Sham Sites
Time frame: From time of first treatment through 2 to 3 days after last treatment.
Number of Participants Who Are Diagnosed With Bacteremia During the Study
Time frame: 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
Time frame: From time of first treatment through 2 to 3 days after last treatment.
Death While Enrolled in Study
Time frame: From time of first treatment through 2 to 3 days after last treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35703367Kudchadkar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane L Di Gennaro, MD, MS principal investigator
Seattle Children's Hopsital
Anne Lynn, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Agitation, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Dexmedetomidine mcg/kg/Day (time frame: from time of first acupuncture/sham treatment till time of extubation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01848158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.