Sickle Cell Anemia Crisis
Conditions
Keywords
sickle cell, acetaminophen in pain crises, opioid-sparing
Brief summary
The purpose of this study is to determine whether IV acetaminophen can decrease the need for subsequent opioid administration in the acute management of sickle cell crisis pain in the pediatric emergency room.
Detailed description
This is a single-center, prospective, randomized, double-blinded, controlled study in an academic urban pediatric emergency department of children with sickle cell disease presenting with acute sickle cell crisis pain between ages of 4 to 16 years, with a pain score of 6/10 or higher on the Wong-Baker modified FACES pain scale. In order to detect a difference of 0.2 mg/kg in cumulative dosage of morphine (at our institution, 0.3 mg/kg morphine deems an inpatient admission for parenteral pain management) with 80% power and alpha of 0.05, we calculated a sample size of 33 patients in each group. All patients will receive IV ketorolac and IV morphine. Patients will be randomized to receive IV acetaminophen or IV saline (volume-equivalent). Pain scores will be obtained at baseline, and again at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after medication administration. Cumulative morphine dosing, rates of admission, and rates of adverse effects of morphine will also be analyzed. Our primary objective is to decrease the need for subsequent opioid administration. Our secondary objectives are to determine if IV Acetaminophen decreases pain score at 30 minutes, 60 minutes, 90 minutes, and 120 minutes, decreases the rate of admissions, and decreases the rate of adverse effects from opioids.
Interventions
Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
Normal saline volume equivalent
Sponsors
Study design
Eligibility
Inclusion criteria
* Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with acute sickle cell pain crisis with a pain of 6/10 or higher
Exclusion criteria
* Patient with fever (38C or 100.4F) * Patient less than age 4 years * Patient greater than age 16 years * Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen * Patient received acetaminophen within the past 4 hours * Patient with known liver disease or renal disease * Patient not requiring IV morphine (pain score 5/10 or less) * Patient enrolled in the study within the past 72 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Opioid Dosing | 120 minutes | Total dosing of opioid given after initial evaluation in mg/kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of the Patients Reporting Satisfaction | 120 minutes | How satisfied were patients with the management of their pain |
| Pain Scores | at disposition | Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse |
| Inpatient Admission | 120 minutes | Percentage of patients admitted to the inpatient unit for parenteral pain management |
| Adverse Effects | 120 minutes | Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients allocated to receive IV acetaminophen
Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen | 35 |
| Placebo Patients allocated to receive IV normal saline placebo
Normal saline: Normal saline volume equivalent | 36 |
| Total | 71 |
Baseline characteristics
| Characteristic | Intervention | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 35 Participants | 36 Participants | 71 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 34 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 35 participants | 36 participants | 71 participants |
| Sex: Female, Male Female | 14 Participants | 20 Participants | 34 Participants |
| Sex: Female, Male Male | 21 Participants | 16 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 36 |
| other Total, other adverse events | 0 / 35 | 0 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 |
Outcome results
Cumulative Opioid Dosing
Total dosing of opioid given after initial evaluation in mg/kg
Time frame: 120 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Cumulative Opioid Dosing | .2 mg/kg |
| Placebo | Cumulative Opioid Dosing | .2 mg/kg |
Adverse Effects
Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration
Time frame: 120 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Adverse Effects | 0 Participants |
| Placebo | Adverse Effects | 0 Participants |
Inpatient Admission
Percentage of patients admitted to the inpatient unit for parenteral pain management
Time frame: 120 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Inpatient Admission | 25 Participants |
| Placebo | Inpatient Admission | 21 Participants |
Pain Scores
Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
Time frame: at disposition
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Pain Scores | 5.5 pain intensity measured on scale 1-10 |
| Placebo | Pain Scores | 5.2 pain intensity measured on scale 1-10 |
Percentage of the Patients Reporting Satisfaction
How satisfied were patients with the management of their pain
Time frame: 120 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Percentage of the Patients Reporting Satisfaction | 84 percent |
| Placebo | Percentage of the Patients Reporting Satisfaction | 85 percent |