Trial Outcomes & Findings for Jackson Pediatric Acupressure for Opioid Tapering (NCT NCT05025384)
NCT ID: NCT05025384
Last Updated: 2025-02-21
Results Overview
The Withdrawal Assessment Tool- Version 1 (WAT-1) monitors opioid and benzodiazepine withdrawal symptoms in pediatric patients. A total of 19 withdrawal symptoms are rated where 0 indicates no symptoms and 10 is worst possible score in indicating intensity of withdrawal.
COMPLETED
NA
40 participants
Baseline to 72 hours
2025-02-21
Participant Flow
Participant milestones
| Measure |
Acupressure Intervention Group
Per protocol, acupressure provided.
|
Control Group
Per protocol, control group.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Acupressure Intervention Group
Per protocol, acupressure provided.
|
Control Group
Per protocol, control group.
|
|---|---|---|
|
Overall Study
Physician Decision
|
5
|
6
|
Baseline Characteristics
Jackson Pediatric Acupressure for Opioid Tapering
Baseline characteristics by cohort
| Measure |
Intervention
n=15 Participants
Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique.
Acupressure: Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Application will occur at designated points including Shen Men, Liver, and Lung: in the room with the mother; and potentially during breast feeding, holding, skin to skin contact or bottle feeds. Stickers will remain in place for 24 hours.
At 24 hours, skin will be assessed, and stickers will then be rotated to the opposite ear every 48 - 72 hours if there are no adverse effects such as skin irritation.
|
No Intervention
n=14 Participants
No intervention
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 72 hoursThe Withdrawal Assessment Tool- Version 1 (WAT-1) monitors opioid and benzodiazepine withdrawal symptoms in pediatric patients. A total of 19 withdrawal symptoms are rated where 0 indicates no symptoms and 10 is worst possible score in indicating intensity of withdrawal.
Outcome measures
| Measure |
Acupressure Intervention Group
n=15 Participants
Per protocol, acupressure provided.
|
Control Group
n=14 Participants
Per protocol, control group.
|
|---|---|---|
|
Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1)
|
3.0 Score on a scale
Interval 1.5 to 4.0
|
3.0 Score on a scale
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Baseline to 72 hoursPrevalence of Delirium will be reported using the preschool confusion assessment method for the ICU (psCAM-ICU). The psCAM-ICU is designed to assess for presence of delirium in critically ill children with or without mechanical ventilation. The psCAM-ICU was designed with cognitive testing that is developmentally appropriate for infants-5 years. Presence of Delirium is assessed using: 1) Acute change or fluctuating course of mental status, 2) Inattention, 3) Altered level of consciousness, 4) disorganized thinking. Presence of number 1) AND number 2) AND either number 3) OR number 4) indicates delirium is present. The following is how the data was coded: '1' for present and '2' for absent.
Outcome measures
| Measure |
Acupressure Intervention Group
n=15 Participants
Per protocol, acupressure provided.
|
Control Group
n=14 Participants
Per protocol, control group.
|
|---|---|---|
|
Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
|
2.0 score on a scale
Interval 2.0 to 2.0
|
2.0 score on a scale
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: Baseline to 72 hoursRASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The primary outcome was median change in RASS score between baseline (immediately before randomized intervention or standard of care) and 72 hours later.
Outcome measures
| Measure |
Acupressure Intervention Group
n=15 Participants
Per protocol, acupressure provided.
|
Control Group
n=14 Participants
Per protocol, control group.
|
|---|---|---|
|
Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS)
|
-0.3 score in a scale
Interval -1.0 to 0.0
|
0 score in a scale
Interval -0.3 to 0.0
|
Adverse Events
Acupressure Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupressure Intervention Group
n=20 participants at risk
Per protocol, acupressure provided.
|
Control Group
n=20 participants at risk
Per protocol, control group.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from baseline to 72 hours post intervention per the protocol
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. There was one adverse event recorded in one participant.
|
0.00%
0/20 • Adverse events were collected from baseline to 72 hours post intervention per the protocol
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. There was one adverse event recorded in one participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place