Trial Outcomes & Findings for Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises? (NCT NCT03541980)
NCT ID: NCT03541980
Last Updated: 2021-04-02
Results Overview
Total dosing of opioid given after initial evaluation in mg/kg
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
120 minutes
Results posted on
2021-04-02
Participant Flow
Participant milestones
| Measure |
Intervention
Patients allocated to receive IV acetaminophen-35
Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
|
Placebo
Patients allocated to receive IV normal saline placebo-36
Normal saline: Normal saline volume equivalent
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
Baseline characteristics by cohort
| Measure |
Intervention
n=35 Participants
Patients allocated to receive IV acetaminophen
Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
|
Placebo
n=36 Participants
Patients allocated to receive IV normal saline placebo
Normal saline: Normal saline volume equivalent
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
71 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
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
37 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
|
34 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
36 participants
n=107 Participants
|
71 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 120 minutesTotal dosing of opioid given after initial evaluation in mg/kg
Outcome measures
| Measure |
Intervention
n=35 Participants
Patients allocated to receive IV acetaminophen
Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
.2mg/kg
|
Placebo
n=36 Participants
Patients allocated to receive IV normal saline placebo
Normal saline: Normal saline volume equivalent
.2mg/kg
|
|---|---|---|
|
Cumulative Opioid Dosing
|
.2 mg/kg
Interval 0.1 to 0.2
|
.2 mg/kg
Interval 0.1 to 0.2
|
SECONDARY outcome
Timeframe: at dispositionScale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
Outcome measures
| Measure |
Intervention
n=35 Participants
Patients allocated to receive IV acetaminophen
Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
.2mg/kg
|
Placebo
n=36 Participants
Patients allocated to receive IV normal saline placebo
Normal saline: Normal saline volume equivalent
.2mg/kg
|
|---|---|---|
|
Pain Scores
|
5.5 pain intensity measured on scale 1-10
Interval 4.3 to 6.6
|
5.2 pain intensity measured on scale 1-10
Interval 4.2 to 6.3
|
SECONDARY outcome
Timeframe: 120 minutesPercentage of patients admitted to the inpatient unit for parenteral pain management
Outcome measures
| Measure |
Intervention
n=35 Participants
Patients allocated to receive IV acetaminophen
Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
.2mg/kg
|
Placebo
n=36 Participants
Patients allocated to receive IV normal saline placebo
Normal saline: Normal saline volume equivalent
.2mg/kg
|
|---|---|---|
|
Inpatient Admission
|
25 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 120 minutesRate of adverse effects experienced by patients from opioid administration vs acetaminophen administration
Outcome measures
| Measure |
Intervention
n=35 Participants
Patients allocated to receive IV acetaminophen
Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
.2mg/kg
|
Placebo
n=36 Participants
Patients allocated to receive IV normal saline placebo
Normal saline: Normal saline volume equivalent
.2mg/kg
|
|---|---|---|
|
Adverse Effects
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 120 minutesHow satisfied were patients with the management of their pain
Outcome measures
| Measure |
Intervention
n=35 Participants
Patients allocated to receive IV acetaminophen
Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
.2mg/kg
|
Placebo
n=36 Participants
Patients allocated to receive IV normal saline placebo
Normal saline: Normal saline volume equivalent
.2mg/kg
|
|---|---|---|
|
Percentage of the Patients Reporting Satisfaction
|
84 percent
Interval 77.2 to 91.8
|
85 percent
Interval 76.2 to 93.4
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place