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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01848158

Enrollment

Registered

2013-05-07

Start date

2013-03-31

Completion date

2016-06-30

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation

Keywords

acupuncture, pediatric, critical care, mechanical ventilation, sedation, comfort

Brief 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.

Interventions

DEVICEacupuncture

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.

DEVICEsham 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 17 Years

Healthy volunteers

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})

Design outcomes

Primary

Measure	Time frame	Description
Average Daily Sedation Score	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).
Average Daily Dexmedetomidine mcg/kg/Day	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)	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)	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).

Secondary

Measure	Time frame
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Acupuncture Acupuncture treatment three times per week for up to two weeks. 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.	10
Sham Acupuncture Sham acupuncture three times per week for up to two weeks 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.	7
Total	17

Baseline characteristics

Characteristic	Acupuncture	Sham Acupuncture	Total
Age, Continuous	2.4 years	1.0 years	1.7 years
PRISM III	0 units on a scale	3 units on a scale	0 units on a scale
Region of Enrollment United States	10 participants	7 participants	17 participants
Sex: Female, Male Female	5 Participants	5 Participants	10 Participants
Sex: Female, Male Male	5 Participants	2 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 7
other Total, other adverse events	0 / 10	0 / 7
serious Total, serious adverse events	0 / 10	0 / 7

Outcome results

Primary

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).

Time frame: from time of first acupuncture/sham treatment till time of extubation

Arm	Measure	Value (MEAN)	Dispersion
Acupuncture	Average Daily Dexmedetomidine mcg/kg/Day	11.08 mcg/kg/day	Standard Deviation 9.37
Sham Acupuncture	Average Daily Dexmedetomidine mcg/kg/Day	17.42 mcg/kg/day	Standard Deviation 6.36

Primary

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).

Time frame: from time of first acupuncture/sham treatment till time of extubation

Arm	Measure	Value (MEAN)	Dispersion
Acupuncture	Average Daily Midazolam Equivalents (mg/kg/Day)	0.73 mg/kg/day	Standard Deviation 1.03
Sham Acupuncture	Average Daily Midazolam Equivalents (mg/kg/Day)	0.97 mg/kg/day	Standard Deviation 0.8

Primary

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).

Time frame: from time of first acupuncture/sham treatment till time of extubation

Arm	Measure	Value (MEAN)	Dispersion
Acupuncture	Average Daily Morphine Equivalents (mg/kg/Day)	1.04 mg/kg/day	Standard Deviation 0.68
Sham Acupuncture	Average Daily Morphine Equivalents (mg/kg/Day)	1.61 mg/kg/day	Standard Deviation 1.12

Primary

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).

Time frame: from time of first acupuncture/sham treatment till time of extubation

Arm	Measure	Value (MEAN)	Dispersion
Acupuncture	Average Daily Sedation Score	29.0 score on a scale	Standard Deviation 20.8
Sham Acupuncture	Average Daily Sedation Score	43.4 score on a scale	Standard Deviation 18.4

Secondary