Sickle Cell Anemia CrisisPhase 4NCT03541980
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
A Phase 4 study testing Acetaminophen and Normal saline in people with Sickle Cell Anemia Crisis, run by Newark Beth Israel Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Anemia Crisis
- What is being tested?
- Acetaminophen and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 20 Feb 2020
- Phase
- Phase 4
- 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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?
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.
Read the 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.
- Conditions
- Sickle Cell Anemia Crisis
- Being tested
- Acetaminophen, Normal saline
- Keywords
- sickle cell, acetaminophen in pain crises, opioid-sparing
- Medical subject headings
- Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Ofirmev, Tylenol
Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
Normal salineDrug
Also called Sodium chloride solution
Normal saline volume equivalent
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Patients allocated to receive IV acetaminophen Receives: Drug: Acetaminophen |
| Placebo | Placebo comparator | Patients allocated to receive IV normal saline placebo Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid Dosing
Total dosing of opioid given after initial evaluation in mg/kg
Measured: 120 minutes
Secondary outcomes (4)
Pain Scores
Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse
Measured: at disposition
Inpatient Admission
Percentage of patients admitted to the inpatient unit for parenteral pain management
Measured: 120 minutes
Adverse Effects
Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration
Measured: 120 minutes
Percentage of the Patients Reporting Satisfaction
How satisfied were patients with the management of their pain
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start20 Feb 2018
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
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 Sickle Cell Anemia CrisisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newark Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cena Tejani, Newark Beth Israel Medical Center
- Investigators
- Cena Tejani, MD, Principal investigator, Children's Hospital of NJ at Newark Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541980
- Sponsor's protocol ID
- 2017.48
- Status last verified
- Mar 2021
- First submitted
- 17 May 2018
- Last updated
- 2 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dhebaria T, Sivitz A, Tejani C. Does Intravenous Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises? Acad Emerg Med. 2021 Jun;28(6):639-646. doi: 10.1111/acem.14149. Epub 2020 Oct 30.
PubMed 33025690
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises?
- ClinicalTrials.gov ID
- NCT03541980
- Acronym / sponsor ID
- 2017.48
- Conditions
- Sickle Cell Anemia Crisis
- Keywords
- sickle cell, acetaminophen in pain crises, opioid-sparing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Newark Beth Israel Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Posted 2 Apr 2021
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 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.
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 |
|---|---|---|
| Intervention | Active comparator | Drug: AcetaminophenPatients allocated to receive IV acetaminophen |
| Placebo | Placebo comparator | Drug: Normal salinePatients allocated to receive IV normal saline placebo |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| AcetaminophenAlso: Ofirmev, TylenolAdministration of 15 mg/kg (1000 mg max dose) of IV acetaminophen | Drug | Intervention |
| Normal salineAlso: Sodium chloride solutionNormal saline volume equivalent | Drug | Placebo |
Primary outcome
Cumulative Opioid Dosing
Time frame: 120 minutes
Total dosing of opioid given after initial evaluation in mg/kg
4 secondary outcomes
Pain Scores
Time frame: at disposition
Inpatient Admission
Time frame: 120 minutes
Adverse Effects
Time frame: 120 minutes
Percentage of the Patients Reporting Satisfaction
Time frame: 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33025690Dhebaria T, Sivitz A, Tejani C. Does Intravenous Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises? Acad Emerg Med. 2021 Jun;28(6):639-646. doi: 10.1111/acem.14149. Epub 2020 Oct 30.
- Individual participant dataSharing planned: Undecided
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Hypoxic Red Blood Cells in Sickle Cell Anemia
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Pain Crisis
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.
Cena Tejani, MD principal investigator
Children's Hospital of NJ at Newark Beth Israel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen and Normal saline in people with Sickle Cell Anemia Crisis, run by Newark Beth Israel Medical Center 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 1 inclusion and 8 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 2 Apr 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2021). 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?
Cumulative Opioid Dosing (time frame: 120 minutes). 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 NCT03541980, 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 2 Apr 2021.